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Sleep Well Live Well (SWELL) Pilot Project

NCT04849572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-02-24

No results posted yet for this study

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).

Conditions

  • Sleep Hygiene

Interventions

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.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2022-05-06
Completion
2022-05-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849572 on ClinicalTrials.gov