Clinical trial NCT04849572: Sleep Well Live Well (SWELL) Pilot Project
Official title: Sleep Well Live Well (SWELL) Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Hygiene
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a permuted block randomization study to assess the efficacy of the new intervention and the primary outcome variable is the sleep time. 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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in total sleep time
timeFrame: 6 Weeks
measure: Change in the ESS in Arm 1 (≥2 points)
timeFrame: 6 Weeks
measure: Change in PSQI at 6 weeks in Arm 1 (≥3 points)
timeFrame: 6 Weeks
Secondary outcomes:
measure: Change in total sleep time
timeFrame: 6 weeks after sleep education
measure: Change in daytime alertness as measured by psychomotor vigilance testing (PVT) in both groups
timeFrame: 6 weeks after sleep education
measure: Change in heart rate variability in both groups
timeFrame: 6 weeks after sleep education
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: