NCT05576090 UCLA REST Study (REsearch on Sleep Techniques)
| NCT ID | NCT05576090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Sleep Disturbance |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-04-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-04-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sleep disturbance has a range of negative effects on psychosocial and biological processes important for academic and social success as well as mental and physical health among adolescents and young adults. Limited, inconsistent, and poor quality sleep lead to anxiety, depressive feelings, loneliness, and fatigue over time. These symptoms, in turn, interfere with the ability to get a good night's rest. Sleep disruption can also upregulate inflammatory processes during the years of adolescence and young adulthood in ways that can create risk for the development of chronic health conditions (e.g., diabetes, depression, cardiovascular disease) in later adulthood. Sleep, however, is also a modifiable health behavior, leading many institutions to embark upon efforts to improve the sleep of their students. The challenge is to identify programs and interventions that can simultaneously improve sleep, be delivered at scale, and be easily completed by students. UCLA has developed and validated a group-based mindfulness intervention, Mindful Awareness Practices (MAPs), that has demonstrated beneficial effects on sleep in adults and may offer a promising, scalable approach for reducing sleep disturbance and improving associated psychological and biological outcomes in college students. However, this approach requires validation in this population relative to sleep education programs, which increasingly dominate the college landscape. To address this important public health problem, the investigators propose to conduct a single site, two-arm, parallel group randomized controlled trial to test the efficacy of the validated, group-based, six-week MAPs intervention vs. sleep education, an active time and attention matched control condition, for first and second year undergraduate students who report poor sleep at this critical transition year. The investigators are aiming to enroll approximately 240 participants. Participants will complete questionnaires, provide blood samples for immune analysis and will be provided with wrist actigraphs to wear for 7 days, in order to collect objective measurements of sleep at pre- and post-intervention visits, and at a 3-month follow-up visit. Additional follow-up assessments will take place at 6-month, and 12-month post-intervention to evaluate persistence of effects.
Eligibility Criteria
Inclusion Criteria: * First or second year undergraduate student at UCLA * Ages 18-22 years old * Must live in the residential halls on UCLA campus * Must have a score of 8 or above on the Insomnia Severity Index (ISI), indicating at least sub-threshold levels of sleep disturbance. Exclusion Criteria * Current diagnosis of mood or anxiety disorder as determined by the PHQ-8 or by the GAD-7 if score \"15\" or more on either measure * Presence of medical conditions or use of medications that may influence sleep or inflammation (e.g., autoimmune disorder) * Previous or current formal instruction in mindfulness meditation (e.g., MAPs, MBSR) or current sleep education program
Contact & Investigator
Julienne E Bower, Ph.D.
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05576090 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 22 Years, studying Sleep Disturbance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05576090 currently recruiting?
Yes, NCT05576090 is actively recruiting participants. Contact the research team at dgaret@mednet.ucla.edu for enrollment information.
Where is the NCT05576090 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05576090 clinical trial?
NCT05576090 is sponsored by University of California, Los Angeles. The principal investigator is Julienne E Bower, Ph.D. at University of California, Los Angeles. The trial plans to enroll 240 participants.