Sleep Well Live Well (SWELL) Pilot Project

NCT ID: NCT04849572

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2022-05-06

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.

Conditions

Sleep Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sleep Education

Also referred to as Arm 1. Arm 1 receives sleep education initially.

Group Type: ACTIVE_COMPARATOR

Sleep Education

Intervention Type: BEHAVIORAL

• 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.

Delayed Sleep Education

Also referred to Arm 2. Arm 2 receives no initial sleep education.

Group Type: ACTIVE_COMPARATOR

Delayed Sleep Education

Intervention Type: BEHAVIORAL

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

References

Sharma S, Stansbury R, Ramadan J, Rojas E, Finomore V, Pham C, Quan SF, Wen S. Sleep well and live well: Impact of sleep hygiene intervention on sleep duration in a rural community: A randomized controlled trial (THE SWELL STUDY). J Rural Health. 2025 Jan;41(1):e70002. doi: 10.1111/jrh.70002.

Reference Type: DERIVED

PMID: 39930329 (View on PubMed)

Other Identifiers

2103262999

Identifier Type: -

Identifier Source: org_study_id