NCT04849572

Sleep Well Live Well (SWELL) Pilot Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Sleep Hygiene

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Education	* Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks. * Week 3: 50 participants (Arm 1) will watch a 10 to 20 minute sleep hygiene video followed by a post-test questionnaire to confirm participation and understanding. * Week 5: Arm 1 will again view the educational video at week 5 * Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling). * Week 9: Arm 1 will continue re-education * Week 11: Arm 1 continues education * Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups.
BEHAVIORAL	Delayed Sleep Education	* Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks. * Week 3: 50 participants (Arm 2) will be controls with no education. * Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling). * Week 9: Arm 2 will join in for video education along with post-test * Week 11: Arm 2 will undergo reeducation with post-test for 20 mins * Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups.

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-05-06
• Completion: 2022-05-06
• First posted: 2021-04-19
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States