91 Day
Sleep Quality and Fatigue Monitoring Protocol
STUDY TITLE | Sleep Quality and Fatigue Monitoring Protocol |
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Submitted under umbrella | |
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 | |
Author edit | |
Informed consent |
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Study author |
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Principal investigator |
Matthew Amsden |
Sub-Investigator for Adverse Events |
Dr. Viral Patel |
Description |
The protocol comprises a 90-day tracking of sleep patterns and fatigue levels. For the first 30 days, participants will monitor their sleep without the aid of any devices. Starting on Day 31, participants will begin to use connected health devices like an Apple Watch, Fitbit, or Oura Ring for sleep tracking. Sleep quality, fatigue levels, and sense of self-agency will be evaluated using the PROMIS Sleep Disturbance Scale, the Neuro-QOL Item Bank v1.0 -Fatigue- Short Form, and the Sense of Agency Scale. |
Participant engagement length |
91 Days |
Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
Cost to participant |
$0 |
Included products & services | |
Outcome measures | |
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 |
Recruitment jurisdictions |
United States, United Kingdom |
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
The Intervention
Included Products & Services
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Study Design & Experience
Statistical Analysis Plan
Limitations & Justification
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
Suitability for Pay to Participate Model
Human Subjects Protection Questionnaire
Logging
Logging
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Sep 07, 2024 16:56:01 | modified | ruthiedellit72 | |
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