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Mindfulness Meditation for Sleep Disorders (REST Trial)

N/A
Recruiting
Led By Andrew Fuligni, Ph.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-intervention; 3, 6, and 12-month follow-up
Awards & highlights

REST Trial Summary

This trial aims to test if a mindfulness intervention can help improve sleep, reduce anxiety, and prevent chronic health problems in college students.

Who is the study for?
The UCLA REST Study is for first-year undergraduate students at UCLA, aged 18-20, living in campus dorms and experiencing sleep issues as indicated by a score of 8+ on the Insomnia Severity Index. Students with mood or anxiety disorders, certain medical conditions, or prior mindfulness meditation instruction are not eligible.Check my eligibility
What is being tested?
This study tests whether a six-week group-based mindfulness program (MAPs) can improve sleep and reduce inflammation compared to standard sleep education. It involves questionnaires, blood samples for immune analysis, and wrist actigraphs to track sleep before and after the intervention plus follow-ups.See study design
What are the potential side effects?
While there are no direct side effects mentioned for MAPs or sleep education interventions being tested in this trial, participants should be aware that any changes in their routine could temporarily affect their sleeping patterns.

REST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-intervention; 3, 6, and 12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention; 3, 6, and 12-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep quality from baseline to post-intervention on the Pittsburgh Sleep Quality Index (PSQI)
Secondary outcome measures
Change in actigraphy-based objective sleep measures from baseline to post-intervention.
Change in anxiety from baseline to post-intervention on the Generalized Anxiety Disorder- 7 (GAD-7).
Change in depressive symptoms from baseline to post-intervention on the Center for Epidemiological Studies Depression Scale (CES-D)
+11 more

Side effects data

From 2016 Phase 2 trial • 413 Patients • NCT01654289
9%
Musculoskeletal
6%
Cardiac Disorders
5%
General
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exercise
Wait-list Control
Mindfulness Meditation

REST Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness MeditationExperimental Treatment1 Intervention
Half of the subjects will be randomly assigned to participate in the Mindfulness Meditation intervention. This class will meet once a week, for two hours, over the course of six weeks.
Group II: Sleep EducationActive Control1 Intervention
Half of the subjects will be randomly assigned to participate in the Sleep Education intervention. This class will meet once a week, for two hours, over the course of six weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Meditation
2017
Completed Phase 2
~4780

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,264,468 Total Patients Enrolled
Andrew Fuligni, Ph.D.Principal InvestigatorUniversity of California, Los Angeles
Julienne E Bower, Ph.D.Principal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
121 Total Patients Enrolled

Media Library

Mindfulness Meditation Clinical Trial Eligibility Overview. Trial Name: NCT05576090 — N/A
Sleep Disorder Research Study Groups: Mindfulness Meditation, Sleep Education
Sleep Disorder Clinical Trial 2023: Mindfulness Meditation Highlights & Side Effects. Trial Name: NCT05576090 — N/A
Mindfulness Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05576090 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this experiment?

"The primary end-point of this clinical trial, assessed at the Baseline, 8 weeks and 20 week marks, is Worries about Sleep. Additionally, psychological wellbeing will be gauged using a 14 item Mental health Continuum-Short Form; self-kindness through a 5 point Self Compassion Scale; as well as fatigue via the Multidimensional Fatigue Symptom Inventory-Short Form general fatigue subscale."

Answered by AI

Does this study consider participation from those younger than 60 years of age?

"In alignment with the eligibility requirements, this medical trial only accepts patients between 18 and 20 years of age as participants."

Answered by AI

Who is qualified to partake in this experiment?

"This investigation is searching for 240 participants, aged 18-20 and with at least some degree of psychosocial functioning. Additional criteria include being a first year undergraduate student attending UCLA, living in the residential halls on campus, and having an Insomnia Severity Index score of 8 or above - signifying sub-threshold levels of sleep disruption."

Answered by AI

Is registration for this trial still available?

"This clinical trial has ceased enrollment, as noted on the page hosted by clinicaltrials.gov. The study was first posted in April of 2023 and last modified in October 2022; however, 486 other studies are currently inviting participants to register."

Answered by AI
~160 spots leftby Dec 2027