35 Day

WavWatch sleep Phase II

STUDY TITLE	WavWatch sleep Phase II
Submitted under umbrella	Umbrella Protocol for Efforia Personalized Agentic Hypothesis Discovery & Experiential Proof Trials
Date submitted	—
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	Preview
Informed consent	Review
Study author	Joseph Bamber, John Bamber, Linda Bamber, Matthew Amsden, Fahad Ijaz
Principal investigator	Matthew Amsden
Sub-Investigator for Adverse Events	Dr. Viral Patel
Description	A 35-day prospective single-arm study evaluating whether nightly WAVwatch use is associated with improvements in sleep disturbance. The study includes a 7-day untreated baseline period followed by 28 days of WAVwatch use. PROMIS Sleep Disturbance is the primary outcome. Sleep-related impairment and fatigue are secondary outcomes. Participant-facing language is intentionally neutral because the study is designed to measure whether sleep changes, not to assume benefit.
Participant engagement length	35 Days
Sponsor	This study is made possible by your payment to cover all supplies and expenses required to participate.
Cost to participant	$597
Included products & services	WAVwatch 2.2 Preorder: $697
Outcome measures	PROMIS Sleep Disturbance Scale Neuro-QOL Item Bank v1.0 –Fatigue – Short Form PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey
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
Commitment 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

The Intervention

Participants use WAVwatch nightly for 28 days following a 7-day untreated baseline period. WAVwatch is a consumer wrist-worn sound-frequency device. Participants are instructed to use the sleep-related frequency set at bedtime according to study directions and manufacturer-supported use.

Included Products & Services

Product Name: WAVwatch 2.2 Preorder

Quantity included: 1

Price: $697.00

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Product Image: WAVwatch 2.2 Preorder

Ingredients: graphite

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Include: adults who can consent, understand English study materials, follow study procedures, and report at least some room for improvement in sleep.

Exclude or seek medical guidance before participation: individuals with severe or untreated sleep disorders requiring medical evaluation; known significant sound sensitivity; conditions making wrist-device use inappropriate; pregnancy or nursing when the participant or clinician considers the intervention inappropriate; or circumstances that would make adherence or interpretation unreliable.

Participants should avoid intentionally starting or stopping other sleep-focused interventions during the study when possible. Necessary medical treatment should never be delayed for research purposes.

Study Design & Experience

This is a prospective, single-arm, within-person Phase II signal study. Participants complete an untreated 7-day run-in followed by 28 days of WAVwatch use. The study uses a clearly prespecified primary endpoint, lower-burden intermediate assessments, explicit endpoint-specific task IDs, treatment expectancy measurement, adherence and safety monitoring, and planned daily sleep diaries. Results shown during treatment should not reveal outcome-score trends; personal results are intended to be presented after the final assessment to reduce feedback-induced response bias.

Statistical Analysis Plan

The primary analysis will be a paired within-participant comparison of PROMIS Sleep Disturbance at the end of the untreated baseline period versus Treatment Day 28. Report N with paired data, baseline and follow-up means and standard deviations, mean paired change with 95% confidence interval, paired t-test where appropriate, a nonparametric sensitivity analysis, and standardized within-person effect size. Secondary paired analyses will evaluate PROMIS Sleep-Related Impairment and Neuro-QOL Fatigue. PROMIS Sleep Disturbance at Treatment Days 7, 14, and 21 will be analyzed longitudinally as supportive trajectory data rather than separate primary hypotheses. Treatment expectancy will be examined as an exploratory covariate/moderator. Per-protocol sensitivity analyses should consider adherence. Major concomitant sleep-intervention changes, illness, or travel should be flagged. Missing outcomes will not be silently imputed in the primary analysis; paired-complete-case results and missingness will be reported transparently.

Limitations & Justification

This is an unblinded single-arm study and therefore cannot establish causal efficacy to the same degree as a randomized controlled trial. Expectancy effects, regression to the mean, natural variation in sleep, concurrent behavior changes, and selective adherence may contribute to observed improvements or worsening. The 7-day untreated baseline, expectation measurement, explicit treatment timing, neutral participant language, adherence tracking, and repeated primary-outcome measurements are intended to improve interpretability while preserving a pragmatic consumer-research design. Positive findings should be treated as a signal supporting a future controlled study.

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

The intervention is a legally available consumer wellness device used in a non-invasive manner. Study activities consist primarily of self-reported assessments, device use consistent with consumer availability, and safety monitoring. The design does not involve deception, invasive procedures, investigational drugs, or medically directed changes in care and is intended to remain within minimal-risk research boundaries.

Suitability for Pay to Participate Model

Participants receive the WAVwatch product and research-related tracking/analysis as part of participation. The study price is aligned with the existing WAVwatch study and reflects a product that is otherwise commercially available. Participation is voluntary, the possibility of no benefit is disclosed, and research language must not imply that benefit is expected or guaranteed.