42 Day

Porn Abstinence Impact: Nighttime Erection Trial

STUDY TITLE Porn Abstinence Impact: Nighttime Erection Trial
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

Apr 19, 2026

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

Recruitment page preview

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Author edit

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Informed consent

Review

Study author

Christos Konstantinidis, Jordan Tsanev, Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

So many of us use porn, but we don't really know how (or if) it affects us. This porn abstinence challenge looks at the impact of a 30 days of porn abstinence - specifically on your nighttime erections using the Adam Sensor, a connect health device to measure your penile tumescence (erections while you sleep) - an incredibly important measure for hormonal and sexual health in men.

Participant engagement length

42 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$249

Included products & services
Adam Sensor – Nocturnal Erection Tracker: $249
Outcome measures

International Index of Erectile Function Survey

Adam Sensor: Nocturnal Penile Tumescence

AGING MALE SYMPTOMS SCALE (AMS)

Daily Men's Health Checkin

Weekly Porn Consumption Survey

Perceived Stress Scale (Past Week Version)

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

Yes

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

**Why I Created This Study:

** In the digital age, our screen time is skyrocketing, with a large portion dedicated to adult content consumption. While conventional wisdom and whispered myths suggest it influences our sexual health, rigorous scientific evidence remains scant. Enter the "Porn Abstinence Impact: Nighttime Erection Trial," where we harness the power of the Adam Sensor to decode the mysteries behind porn abstinence and its effects on nocturnal erections—a pivotal marker of male sexual vitality. It's time to separate fact from fiction and uncover the truth behind our nighttime tent-pitching prowess.

**My Objective for You:** With this study, I aim to empower you to understand how abstaining from porn for 30 days could impact your sexual health, specifically through the lens of nighttime erections. By leveraging the Adam Sensor, we will provide you with personalized insights into your hormonal and sexual health, enabling you to make informed decisions about your screen habits and explore alternative activities that enhance your overall well-being.

**Aims & Objectives:** This study seeks to elucidate the influence of porn abstinence on nocturnal penile tumescence using the Adam Sensor, providing you with personalized data. By participating, you'll gain valuable insights into how this lifestyle change could affect your erections and, by extension, your hormonal and sexual health, helping you make informed decisions about your time and resources.

**Significance & Impact:** By participating in this study, you contribute to a groundbreaking exploration of the intersection between digital habits and sexual health. Expected outcomes include a deeper understanding of how reduced porn consumption may affect nocturnal erections, potentially reshaping perspectives on modern screen usage. While limitations exist, such as individual variability in response, the personalized data you receive could be transformative, offering a compass for navigating your sexual health landscape.

The Intervention

The intervention focuses on 30 days of porn abstinence to evaluate its impact on nocturnal erections, using the Adam Sensor. Scientific evidence remains divided; some studies link excessive porn use to reduced sexual satisfaction, while others see it as part of healthy sexuality. Medical consensus is not established, but the study aims to provide personal insights into hormonal and sexual health. Social media buzzes with mixed opinions, reflecting the general population's curiosity and concerns about potential benefits and risks.

Included Products & Services

Product Name: Adam Sensor – Nocturnal Erection Tracker

Quantity included: 1

Price: $249.00

Product Description: You monitor your steps, calories, and even your credit score. Now, it's time to keep an eye on something crucial for many—your manhood's health. The Adam Sensor offers advanced technology to track erection health and gives you a chance to join leading studies in male wellness, uncovering new insights.

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.

Based on the intervention and outcome measures, here is a table identifying the kinds of people who should avoid being part of this trial:

Category of Individual Contraindications Reason
Individuals with Sexual Dysfunction History Existing sexual dysfunction conditions Participation may exacerbate symptoms or interfere with ongoing treatments.
Individuals with Mental Health Disorders Current or history of mental health issues The intervention might impact mental health stability, especially for those with anxiety or depression.
Individuals with Addictive Behaviors History of pornography addiction or other addictions Abstinence could trigger withdrawal symptoms or lead to psychological distress.
Individuals on Hormonal Therapy Ongoing hormonal treatments or conditions affecting hormones The intervention may interfere with or skew the results due to hormonal imbalances.
Individuals in Unstable Relationships Experiencing relationship issues or conflicts The intervention could strain relationships or exacerbate personal conflicts.
Individuals with Privacy Concerns High concern for privacy regarding sexual health The study involves sensitive topics that might cause discomfort or privacy issues.
Individuals with Cultural or Religious Considerations Cultural or religious beliefs opposing the study's nature Participation may conflict with personal beliefs or social norms, causing distress.

Participants should carefully consider their personal health, mental well-being, and social circumstances before deciding to join the study.

Study Design & Experience

Treatment activities:

Week 1: Baseline Observation (Days 1–7) - Continue normal porn usage to establish a baseline. Days 8–38: Abstinence Period - Attempt to abstain from pornography for 30 days, logging any slips as data.

Assesments and frequency:
  • Baseline and Weekly: Use the Adam Nocturnal Erection Tracker to monitor nighttime erections. Complete baseline surveys (e.g., International Index of Erectile Function, Sexual Desire Inventory) and weekly porn consumption surveys. - Every 7 days: Check in to track nighttime erections, mental clarity, libido, mood, energy, and emotional resilience.
Methodology:

This porn abstinence Impact trial is an observational trial designed to investigate the potential effects of a 30-day period of pornography abstinence on nocturnal erections. Utilizing the Adam Sensor, a connected health device, the study measures penile tumescence during sleep—a critical marker of hormonal and sexual health in men. This study, conducted under the "Minimal Risk Umbrella protocol," serves as a "Signal Phase" trial at Efforia, where participants act as their own controls. By comparing baseline data with post-abstinence outcomes, the study aims to provide initial insights into the physiological impacts of pornography abstinence, thus offering a directional indication of potential positive results and contributing to the limited existing safety data.

The study experience is structured into a 40-day period where participants first establish a baseline during the initial week by maintaining their usual pornography consumption habits. This baseline period is crucial for capturing a snapshot of each participant's current physiological state, including the frequency and quality of nocturnal erections. Following this, participants enter a 30-day abstinence phase, during which they attempt to refrain from any form of pornography, with an emphasis on intention over perfection. Throughout this period, key variables such as nighttime erections, mental clarity, libido, mood, and energy levels are meticulously tracked. Efforia provides guidance via digital tools to ensure consistency and privacy in data collection, encouraging participants to reflect and report without judgment.

Should the trial indicate a positive signal, meaning the intervention (pornography abstinence) appears effective, more comprehensive study designs may be pursued to further validate these findings. The Adam Sensor, central to this study, offers a comfortable and discreet means of tracking nocturnal erections by measuring changes in penile circumference, transmitting data to the AdamHealth app for detailed analysis. Participants are encouraged to engage with their data insights over time, facilitating a deeper understanding of their individual responses to the intervention. This initial phase not only serves to explore the potential health benefits of pornography abstinence but also lays the groundwork for future research directions that could refine our understanding of its impact on male sexual health. For more detailed information, refer to the "Minimal Risk Umbrella protocol."

Statistical Analysis Plan

You are analyzing data from a registered single-arm longitudinal citizen science study (Efforia Study ID: 38316) titled "Porn Abstinence Impact: Nighttime Erection Trial" The study evaluates the physiological and psychological effects of 30 days of pornography abstinence in adult males. Participants served as their own controls across a structured 14-day baseline period followed by a 30-day abstinence intervention phase.

Baseline Structure — Critical for Analysis:

The baseline period consists of two distinct phases, each exactly 7 days, that are required but not necessarily sequential.


Baseline Week 1 (Days 1–7 from challenge start): Self-report only. Participants complete daily check-ins, the IIEF, AMS, PSS, and the "How You Feel About Yourself & Porn" survey while maintaining normal pornography habits. No device data is collected during this period.

Baseline Week 2 (7 days, device-dependent): Begins only after the Adam Sensor has been received and the first baseline sensor task (38333) is completed. Participants wear the Adam Sensor nightly and continue daily self-report check-ins. This phase may begin anywhere from immediately after Week 1 to several weeks later, depending on shipping.

The gap between Week 1 and Week 2 is a known, intentional design feature — do not treat it as missing data or dropout. Record the gap duration per participant and test whether gap length is associated with any outcome (it should not be, but verify).

Both phases must be completed before the 30-day abstinence period begins. Treatment start is individually anchored to commitment task completion, not a fixed calendar date.


Other key design features:


Single-arm — all inferential comparisons are within-person (pre vs. post)

Slips during abstinence are logged as data, not exclusion criteria

Participation is self-selected and participant-funded — account for potential selection bias toward men already motivated to reduce pornography use


PRIMARY OUTCOME MEASURES

For each measure, calculate the within-person change score (follow-up minus baseline). Where multiple follow-up assessments exist, use the final available assessment as the primary endpoint and treat intermediate assessments as secondary longitudinal data points.


Nocturnal Penile Tumescence (NPT) — Adam Sensor



Primary metric: Total Erection Time (minutes per night)

Secondary metrics (if available): frequency of erection events per night, average duration per event

Baseline window: All 7 nights of Adam Sensor data from Baseline Week 2 (after device arrival, before abstinence commitment)

Follow-up window: Final 7 days of the abstinence period (Days 23–30 of treatment)

Mid-study reading: Days 10–17 of treatment for longitudinal trajectory analysis

Do not include any sensor data from before the commitment task as treatment-phase data



International Index of Erectile Function (IIEF)



Use total IIEF score and domain subscores: Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction

Baseline: Week 1 administration

Follow-up: Final administration (post Day 30 of treatment)

Compute within-person change for total score and each domain



Aging Male Symptoms Scale (AMS)



Use total AMS score and subscales: Psychological, Somatic, Sexual

Baseline: Week 1 administration

Follow-up: Final administration

Note: Lower AMS scores = fewer symptoms = improvement. Ensure change scores are signed correctly (negative change = improvement)



Perceived Stress Scale (PSS) — Past Week Version



Use total PSS score

Baseline: Week 1 administration only — this is the anchor for stress stratification (see below)

Follow-up: Weekly administrations throughout treatment (repeated measure — analyze as a trajectory, not just endpoint)

Compute both endpoint change and slope across treatment weeks

Do not use Week 2 PSS as baseline — by Week 2, participants are aware of the upcoming commitment and may already be experiencing anticipatory stress or behavioral change



Daily Men's Health Check-In



Variables: mood, energy, libido, mental clarity, emotional resilience

Baseline Week 1 average: aggregate the 7 self-report days

Baseline Week 2 average: aggregate the 7 device-phase days separately

Report both as baseline reference points and note any Week 1 to Week 2 drift — systematic drift during the baseline gap may indicate behavioral anticipation effects

Treatment: weekly averages across the 30-day abstinence period

Model as a time series to capture trajectory shape



Weekly Porn Consumption Survey



Variables: frequency (days/week), estimated duration per session (minutes), slips during abstinence

Baseline: Average across both Week 1 and Week 2 baseline administrations

During treatment: week-by-week slip frequency and recurrence patterns

Compute: proportion with zero slips, 1–3 slips, 4+ slips

Test whether slip frequency moderates primary outcomes


STRATIFICATION VARIABLES

This analysis uses two primary stratification variables, applied independently and in combination.

STRATIFICATION 1 — TREATMENT EXPECTANCY

Definition: The degree to which a participant anticipated positive effects from pornography abstinence prior to beginning the intervention, captured in the Baseline Week 1 "Goals & Expectations" and "How You Feel About Yourself & Porn" tasks.

Operationalization:


Extract all expectancy-relevant items from the Goals & Expectations task (lesson ID: 90761) — items asking participants to rate anticipated improvement, expected difficulty, motivation for joining, and prior beliefs about pornography's effects

Construct a Treatment Expectancy Index (TEI) as a composite score. Sum or average Likert-scale items. For open-text responses, apply sentiment scoring (positive/negative/neutral) and convert to a numeric scale

Document TEI distribution, skewness, and floor/ceiling effects before splitting

Apply a median split: High Expectancy (HE) at or above the median, Low Expectancy (LE) below the median

Sensitivity analysis: run all analyses using tertile splits (Low / Medium / High) and report consistency


STRATIFICATION 2 — BASELINE PERCEIVED STRESS

Definition: A participant's self-reported stress level at study entry, captured by the PSS administered during Baseline Week 1. This stratification tests whether men entering the study under higher psychological stress show different physiological and behavioral responses to pornography abstinence.

Rationale: High baseline stress may amplify withdrawal-like symptoms during abstinence, suppress or enhance NPT recovery, and interact with pornography use patterns. Stress may also serve as a confounder if not accounted for — stressed men may use pornography more frequently at baseline, making their abstinence-period changes larger but potentially regression-to-mean driven.

Operationalization:


Use the Week 1 PSS total score as the stratification anchor

Apply PSS published clinical cut-points where available, or apply a median split: High Stress (HS) at or above the median, Low Stress (LS) below the median

Also test using PSS tertiles (Low / Moderate / High stress) as a sensitivity analysis

Document the PSS distribution at baseline — if the sample skews high, as expected in self-selected men seeking behavioral change, note this explicitly and consider whether tertiles better represent clinically meaningful distinctions than a median split

For the PSS outcome analysis: use Week 2 and treatment-phase PSS scores as longitudinal follow-up points, anchored to the Week 1 baseline value established for stratification


COMBINED STRATIFICATION — 2x2 EXPECTANCY x STRESS MATRIX

In addition to independent stratification, construct a 2x2 matrix crossing expectancy and stress groups. The four cells are HE-LS (High Expectancy, Low Stress), HE-HS (High Expectancy, High Stress), LE-LS (Low Expectancy, Low Stress), and LE-HS (Low Expectancy, High Stress).


Report sample sizes per cell — flag if any cell has n < 10 as underpowered for subgroup analysis

For each primary outcome, report mean change scores across all four cells

The most theoretically interesting contrasts are:

HE-LS vs. LE-HS — motivated, low-stress men vs. skeptical, high-stress men — tests whether psychological starting conditions predict differential physiological response

HE-HS vs. LE-HS — among high-stress men, does expectancy still matter?

HE-LS vs. HE-HS — among motivated men, does baseline stress moderate outcomes?


CORE ANALYSES

Analysis 1 — Primary Outcome Change by Expectancy Group

For each primary outcome measure:


Compute mean within-person change score for HE and LE groups separately

Report mean, SD, 95% CI, effect size (Cohen's d) for each group

Test between-group differences using independent samples t-test or Mann-Whitney U

Report p-values with appropriate caution given sample size and single-arm design


Analysis 2 — Primary Outcome Change by Stress Group

Replicate Analysis 1 exactly, substituting HS vs. LS as the grouping variable.


Pay particular attention to the AMS Psychological subscale and PSS trajectory — these are the measures most likely to show stress-group differences

Test whether HS participants show greater PSS reduction during abstinence (stress relief hypothesis) or greater PSS elevation (withdrawal/adjustment hypothesis)

Compare NPT change between HS and LS groups — test whether high-stress men show different nocturnal erection trajectories independent of expectancy


Analysis 3 — NPT Trajectory Analysis

Using the Adam Sensor data:


Plot mean nightly Total Erection Time across the study timeline for all four stratification groups (HE, LE, HS, LS) and all four 2x2 cells

Fit a mixed-effects model with time (week of study) as a within-person factor, expectancy group and stress group as between-person factors, an expectancy x stress interaction term, and time x expectancy, time x stress, and time x expectancy x stress interaction terms

Account for variable baseline start dates by anchoring time to individual treatment start dates

Account for the Week 1 / Week 2 gap by using device-on days for NPT calculations, not calendar days


Analysis 4 — Slip Analysis


Compare slip frequency between HE vs. LE groups and HS vs. LS groups

Test whether expectancy and/or stress predict slipping using logistic regression (any slip vs. no slip) and Poisson regression (slip count) with expectancy and stress as predictors

Test whether slips moderate primary outcomes — do participants who slipped show attenuated NPT improvement?

Examine whether high-stress participants slip more frequently and whether this accounts for any HS vs. LS outcome differences (stress → slipping → attenuated outcomes mediation)


Analysis 5 — Dose-Response: Baseline Porn Use vs. Outcomes


Stratify by baseline pornography consumption: Low (2 days/week or fewer), Moderate (3–5 days/week), High (6 or more days/week)

Within each stratum, compare outcome change scores

Cross-tabulate with both expectancy and stress groups — do high-consumption men cluster in particular expectancy/stress cells?

Flag regression to mean risk if high consumers show disproportionate improvement


Analysis 6 — Stress as a Mediator of NPT Change


Test whether reduction in PSS during abstinence mediates NPT improvement

Specifically test whether the pathway abstinence → stress reduction → NPT improvement holds as a mediating chain

Use bootstrapped mediation (5000 iterations), report indirect effect with 95% CI

Run separately within HE and LE groups — does the stress-mediation pathway operate equally across expectancy groups, or is it stronger in one?


Analysis 7 — Completers vs. Non-Completers


Define completers as participants who: completed the 30-day abstinence period, submitted 80% or more of daily check-ins across both baseline phases and treatment, and have baseline and follow-up data for at least one primary outcome

Compare baseline PSS, TEI, IIEF, AMS, and porn consumption between completers and non-completers

Test whether HE predicts completion using logistic regression

Test whether HS predicts dropout — does high stress make participants more likely to leave?

Conduct sensitivity analysis running all primary analyses on completers only vs. full available sample


SECONDARY & EXPLORATORY ANALYSES


Daily Users subgroup: isolate daily baseline porn users, compare their expectancy and stress profiles to non-daily users, and test whether they show larger NPT improvements

Time to first slip: Kaplan-Meier survival curves stratified by expectancy group and stress group separately

Self-report vs. objective concordance: compare IIEF erectile function subscale change with NPT change and test whether concordance is higher in HE or LS groups

Baseline Week 1 to Week 2 drift: test whether daily check-in scores (mood, libido, energy) change systematically during the gap between Week 1 and Week 2. If they do, this suggests anticipatory behavioral change before the commitment task and should be reported as a potential confound

Gap duration effect: test whether the length of the Week 1 to Week 2 gap (shipping delay) correlates with any outcome. It should not. If it does, investigate whether longer-gap participants differ behaviorally from shorter-gap participants

Responder analysis: define a meaningful responder as 20% or greater improvement in NPT combined with a 5-point or greater IIEF improvement. Report responder rates across all stratification groups and all four cells of the 2x2 matrix

Week-by-week PSS trajectory by stress group: test whether the HS group shows an early stress spike before later reduction and whether the LS group shows monotonic decline. Plot and compare trajectory shapes across both baseline weeks and all treatment weeks


STATISTICAL REPORTING STANDARDS


Report exact p-values throughout

Report effect sizes with 95% CI for all primary comparisons

Use two-tailed tests throughout

Apply Bonferroni correction for the family of primary outcome comparisons across both stratification variables — adjusted alpha accounts for 6 outcomes x 2 stratification variables = 12 primary comparisons (adjusted alpha = 0.0042)

Flag results significant at unadjusted but not Bonferroni-corrected thresholds as nominally significant

For all mixed models, report fixed effects, random effects structure, AIC/BIC

For the 2x2 matrix analyses, report all cell results even where underpowered — note power limitations explicitly rather than suppressing results

Present null and negative findings with equal prominence to positive findings


CONFOUND & BIAS ASSESSMENT

Flag and discuss the following:


Selection bias: self-selected, participant-funded sample. Assess whether baseline characteristics suggest a population predisposed to benefit

Expectancy-performance bias: HE participants may report better outcomes on subjective measures regardless of true physiological change. NPT is the critical objective check. If HE shows larger subjective but not objective gains, flag explicitly

Stress-confounding: high baseline stress may drive both higher baseline porn consumption and greater apparent improvement, creating spurious treatment effects. The HS vs. LS stratification is partly designed to detect this

Regression to the mean: high baseline consumers and high-stress participants may show apparent improvement due to regression. Cross-check NPT (objective) against self-report

Device compliance: flag participants with fewer than 4 nights of Week 2 baseline data or fewer than 10 nights of treatment data as potentially unreliable for NPT analysis

Week 1 / Week 2 gap behavioral contamination: participants aware of the upcoming abstinence commitment may reduce pornography use during the gap period even before officially committing. Test whether baseline Week 2 pornography consumption is lower than Week 1 at the group level. If so, document as a protocol-level limitation

Slip contamination: conduct per-protocol analysis excluding participants with more than 3 slips in the final 14 days of treatment


OUTPUT FORMAT

Present findings in the following structure:


Sample characteristics table: n overall and per stratification cell, baseline scores for all measures, TEI distribution, PSS distribution, 2x2 cell sizes

Primary outcomes table: mean change scores, SD, 95% CI, Cohen's d, p-value for each measure by expectancy group, stress group, and overall

2x2 matrix outcomes table: mean NPT change and IIEF change for all four cells

NPT trajectory figure: line graphs of mean weekly NPT by expectancy group and by stress group as two separate figures with error bars

PSS trajectory figure: week-by-week PSS means by stress group across baseline and treatment phases

Responder analysis table: meaningful responder rates across all stratification groups

Slip analysis summary: slip rates, time-to-first-slip curves stratified by both expectancy and stress, moderation results

Narrative interpretation covering: (a) whether objective NPT data support subjective self-report findings, (b) whether expectancy group differences suggest expectancy bias or genuine differential response, (c) whether stress group differences suggest stress as a moderator, mediator, or confounder of abstinence effects, (d) the pattern across the 2x2 matrix and which cell shows the strongest response and what this implies, and (e) implications for future RCT design including what should be stratified at randomization, what covariates should be collected, and what sample size would be needed to power the key comparisons based on observed effect sizes


LANGUAGE & FRAMING GUIDANCE


Present all findings as exploratory and hypothesis-generating, not confirmatory

Use associative language throughout — "abstinence was associated with" not "abstinence caused"

Explicitly acknowledge the absence of a control group in all interpretive statements

Where HE and LE groups show similar outcomes, frame as evidence against pure expectancy bias

Where HS and LS groups show similar outcomes, frame as evidence against stress as a primary moderator

Where findings are null or mixed, report with equal prominence to positive findings

Avoid language implying pornography is inherently harmful or beneficial — the study is explicitly neutral on this question


Limitations & Justification

This single-arm observational study, conducted under the Minimal Risk Citizen Science Umbrella Protocol, explores the impact of 30 days of pornography abstinence on men's sexual health, particularly focusing on nocturnal erections as a biomarker. While the absence of a control group inherently limits the ability to draw causal inferences, the study design incorporates an expectations questionnaire to quantify potential biases related to participant preconceptions. By having participants act as their own controls and using validated tools like the Adam Sensor, we aim to mitigate some of the bias inherent to single-arm trials. This ensures that any changes observed in nocturnal penile tumescence, sexual desire, and mental health are carefully contextualized, providing a more robust understanding of the effects of porn abstinence.

The study's reliance on self-reported data and the use of a commercial device like the Adam Sensor represent additional limitations. Self-reported data can be subjective and prone to bias, while the Adam Sensor, although non-invasive and valuable for personal health monitoring, may not capture the full complexity of physiological changes. To address these limitations, the study employs validated surveys alongside the sensor, allowing for a triangulated approach to data collection. Additionally, stratifying the data by demographic variables will permit a nuanced analysis that may highlight patterns otherwise obscured by aggregate data. These methodological considerations are designed to enhance the study's validity and reliability, despite the inherent constraints of the single-arm design.

Efforia's Minimal Risk Umbrella Protocol is driven by a mission to democratize clinical research, supporting inquiries that might otherwise be overlooked. By focusing on personal insights and broader implications, this study aligns with Efforia's goals, providing valuable data that can inform future, more rigorous investigations if promising signals are detected. Participants gain access to personal insights about their health, while the broader research community benefits from a study that contributes to the ongoing conversation about the impact of pornography on male health. For more information on the protocol and its objectives, individuals are encouraged to refer to the Minimal Risk Umbrella Protocol.

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Yes, this study might appear unsuitable for the inclusion under the minimal risk umbrella protocol. While the title suggests a focus on sexual content, it is specifically to avoid this content. It is exactly the opposite of titillation. The study is designed for a broad audience. And given the current cultural conversation around the overuse of porn among all individuals (specifically men), and the increased focus in general men’s sexual health this is not specifically targeting those with any specific vulnerabilities.

Yes, the study collects some sensitive information. It does involve sensitive personal data. But no more or no less than some other minimal risk study protocols on the platform. The study specifically asks individuals to avoid sexual content (and it does not depict violence). And therefore actually meets the criteria for minimal risk.

Suitability for Pay to Participate Model

The "Porn Abstinence Impact: Nighttime Erection Trial" study proposes to charge participants $149 for the Adam Sensor, a nocturnal erection tracker. This device is legally available on the open market in the United States, where similar health monitoring devices are often sold to consumers interested in tracking various aspects of their health. The Adam Sensor provides a unique value proposition by offering specific insights into nocturnal erections, which are critical measures of hormonal and sexual health in men. Participants in this study are likely to be individuals who are already interested in personal health monitoring and sexual health, and therefore, may be generally willing to pay for such a specialized product. Furthermore, health and wellness devices with similar functions or benefits are often available at comparable or higher price points, suggesting that the Adam Sensor is reasonably priced within this market.

Additionally, the study offers more than just the convenience of purchasing the device. Participants gain access to a structured research environment that provides additional context and interpretation of the data collected by the Adam Sensor. This added value supports informed decision-making regarding their health, beyond what might be available through simple retail purchase. The typical consumer targeted by this study, likely interested in sexual health and wellness, is expected to afford the $149 cost without experiencing severe financial hardship. The study also carefully considers participant vulnerabilities by ensuring transparency and informed consent, minimizing the risk of buyer’s remorse. Overall, the opportunity to contribute to scientific understanding while receiving valuable personal health insights justifies the participant cost in this study.

Human Subjects Protection Questionnaire

Beneficence

  1. Is there a description, unambiguous research question, and purpose? Yes, the study clearly outlines its research question and purpose, focusing on evaluating the effectiveness of a specific product or service offered by Efforia. This clarity ensures the study's objectives are well-defined and easily understood by participants and researchers alike.

  2. Is the study built on what is known already? Yes, the study builds on existing knowledge by utilizing the Efforia platform, which leverages previous research and real-life experiences of participants to inform its design. This ensures that the study is grounded in a solid foundation of prior findings and insights.

  3. Will the study provide meaningful answers to the research question? Yes, the study is designed to produce generalizable results that are relevant to both the broader research community and the specific participants involved. This dual focus ensures that the study's findings will be significant and applicable.

  4. Will the study provide valid answers to the research question? Yes, the study employs robust methodologies and leverages the extensive infrastructure of the Efforia platform to ensure the validity of its findings. The study's design is carefully crafted to yield accurate and reliable results.

Non-maleficence

  1. Are participants recruited with justifiable inclusion and exclusion criteria? Yes, any individual who has already purchased the product is eligible to participate. Efforia emphasizes participant responsibility by providing clear risks and considerations in the informed consent, ensuring minimal risk protocols are appropriate for each participant.

  2. Does the research team have the experience, skills, facilities, and time to complete the study? Yes, the research team is well-equipped with the necessary experience, skills, and infrastructure from the Efforia platform to conduct decentralized minimal risk studies. The team is led by Matthew Amsden, an expert in decentralized trial management, and supported by Dr. Viral Patel for any adverse events, ensuring comprehensive oversight.

  3. Is there a fair balance of benefits and harms (risks) for all with an interest in the study? Yes, the study's unique approach, as outlined in the minimal risk protocol, offers added value to participants who have purchased the product at no extra cost. This balance ensures that participants benefit from the study while minimizing potential risks.

  4. Will participants receive appropriate care both during and after the study? Yes, participants are advised to seek their own medical care in case of adverse events, as per the informed consent. However, the minimal risk nature of the interventions and the study's monitoring provide more care than participants would receive outside the research context.

  5. Is personal data handled appropriately (confidentiality)? Yes, personal data is managed with confidentiality, as detailed in the Minimal Risk Umbrella protocol, ensuring participant privacy and data protection.

Autonomy

  1. Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process? Yes, the informed consent document is written in plain English and provides comprehensive information about the study, its risks, benefits, and the voluntary nature of participation, allowing participants to make informed decisions.

  2. Has the research incorporated patient and participant views? Yes, the study is designed to incorporate participant feedback, as Efforia is a participant-driven platform. The consent document encourages participants to provide input throughout the study, ensuring their views are considered.

Justice

  1. Are there fair payments for participation and financial recompense in case of harm? Yes, while participants pay to participate, the study offers valuable product tracking and health outcome monitoring, providing intrinsic value. Participants understand that medical care is their financial responsibility in case of adverse events, and they are instructed to report incidents to Efforia.

  2. Do participants have access to an independent complaints procedure (or advocate)? Yes, participants can contact Efforia's support for concerns or complaints and have access to independent ethics review board contacts included in the informed consent, providing multiple avenues for addressing issues.

  3. Will the project be registered and results reported in the public domain? Yes, Efforia is committed to transparency, making personal results immediately available to participants and ensuring that generalizable results contribute to the public domain, enhancing the credibility of the authors and the study.