- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849572
Sleep Well Live Well (SWELL) Pilot Project
August 3, 2021 updated by: Sunil Sharma, West Virginia University
This will be a 12 week randomized control trial of sleep hygiene education vs. no education with a cross-over to the active intervention after 6 weeks.
Primary and secondary outcomes will be assessed before and after a 10-20 minute sleep hygiene video (intervention).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The primary aim of this study is to assess if sleep hygiene education increases sleep duration and sleep quality in an Appalachian community.
To accomplish these aims, the investigators will assess changes in sleep duration by the Oura ring and the PSQI and Epworth Sleepiness Scale (ESS).
Secondary aims are to determine whether sleep hygiene education decreases heart rate variability measured by the Oura ring and improves alertness as assessed by psychomotor vigilance testing (PVT).
Potential participants will be recruited via brochures, poster displays and on-line media to participate in the study.
Those eligible will be asked to complete a questionnaire to record baseline demographics.
The data collected will be demographic information, presence of chronic medical conditions, validated sleep questionnaires, PVT results and Oura ring (https://ouraring.com/)
output.
A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender.
The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start.
Each subject (in both groups) will have pre- and post-intervention data in this study.
Therefore, the "real" control in this study is the subject himself/herself (after taking the difference), which will minimize any confounding factors/effect; If the investigators assume that more education duration will result in more benefit, the investigators have a chance to assess a dose-response curve ("dosage" = education duration).
The investigators will fit a mixed-effects model with duration as a fixed effect, adjusting for potential confounding variables if any.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sunil Sharma, MD
- Phone Number: 304-293-4661
- Email: sunil.sharma@hsc.wvu.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Reside in Harrison County of West Virginia
- Ability to read and understand English
- Ability to provide informed consent
Exclusion Criteria:
- Inability to read and understand English
- Inability or unwillingness to provide informed consent
- Presence of sleep apnea
- Depression
- Severe insomnia
- Using prescription sleeping medication or narcotics
- Acute illness including stroke, heart attack, heart failure or pneumonia with or without COVID-19 infection requiring hospital admission within the last 8 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sleep Education
Also referred to as Arm 1. Arm 1 receives sleep education initially.
|
|
Active Comparator: Delayed Sleep Education
Also referred to Arm 2. Arm 2 receives no initial sleep education.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in total sleep time
Time Frame: 6 Weeks
|
A 20 minute or more difference in total sleep time between Arm 1 (sleep education) and Arm 2 (no initial sleep education).
|
6 Weeks
|
Change in the ESS in Arm 1 (≥2 points)
Time Frame: 6 Weeks
|
The Epworth Sleepiness Scale (ESS) is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness.
The test is a list of eight situations in which the subjects rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
When the subjects finish the test, add up the values of the responses.
The subjects total score is based on a scale of 0 to 24.
The scale estimates whether the subjects are experiencing excessive sleepiness that possibly requires medical attention.
|
6 Weeks
|
Change in PSQI at 6 weeks in Arm 1 (≥3 points)
Time Frame: 6 Weeks
|
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available).
Only self-rated questions are included in the scoring.
The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points.
In all cases, a score of "O" indicates no difficulty, while a score of "3" indicates severe difficulty.
The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "O" indicating no difficulty and "21 " indicating severe difficulties in all areas.
|
6 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total sleep time
Time Frame: 6 weeks after sleep education
|
Change in total sleep time variability (> 1 hour) in both groups.
Changes in sleep duration will be assessed by the Oura ring, a novel sleep monitoring device.
|
6 weeks after sleep education
|
Change in daytime alertness as measured by psychomotor vigilance testing (PVT) in both groups
Time Frame: 6 weeks after sleep education
|
The primary outcome measures of PVT performance, lapses, are defined as reaction times exceeding 500 msec or failure to react.
The PVT lapses are believed to represent perceptual, processing, or executive failures in the central nervous system (CNS).
|
6 weeks after sleep education
|
Change in heart rate variability in both groups
Time Frame: 6 weeks after sleep education
|
Measured by the Oura Ring
|
6 weeks after sleep education
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2021
Primary Completion (Anticipated)
November 1, 2021
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
April 13, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
August 5, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2103262999
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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