Sleep Well Live Well (SWELL) Pilot Project

Sleep Hygiene Clinical Trial

Official title:

Sleep Well Live Well (SWELL) Pilot Project

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04849572
• Other study ID #: 2103262999
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: January 2022

Study information

• Verified date: August 2021
• Source: West Virginia University
• Contact: Sunil Sharma, MD
• Phone: 304-293-4661
• Email: sunil.sharma[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Hygiene

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in total sleep time	A 20 minute or more difference in total sleep time between Arm 1 (sleep education) and Arm 2 (no initial sleep education).	6 Weeks
Primary	Change in the ESS in Arm 1 (=2 points)	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
Primary	Change in PSQI at 6 weeks in Arm 1 (=3 points)	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	Change in total sleep time	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
Secondary	Change in daytime alertness as measured by psychomotor vigilance testing (PVT) in both groups	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
Secondary	Change in heart rate variability in both groups	Measured by the Oura Ring	6 weeks after sleep education