Sleep Well Live Well (SWELL) Pilot Project

West Virginia University

Status: Completed

Conditions: Sleep Hygiene

Treatments: Behavioral: Delayed Sleep Education; Behavioral: Sleep Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04849572

2103262999

Details and patient eligibility

About

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).

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Sleep Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Sleep Education

Delayed Sleep Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Delayed Sleep Education