Recruiting
Phase 1
Phase 2

Mindfulness Meditation

Sponsor:

Brigham and Women's Hospital

Code:

NCT06972303

Conditions

Sleep Initiation and Maintenance Disorders

Insomnia

Insomnia Chronic

Mindfulness

Telemedicine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Instructed bedtime app-guided mindfulness meditation

Uninstructed app-guided mindfulness meditation

Sleep hygiene education

Study Details

Brief summary:

The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.

Conditions

Sleep Initiation and Maintenance Disorders

Insomnia

Insomnia Chronic

Mindfulness

Telemedicine

Study ID

NCT06972303

Start date

Mar 31, 2026

Status verified date

Jun, 2026

Completion date

Dec 29, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years and older;
  • Chronic insomnia (≥ 3 nights/week, for ≥ 3 months), defined by DSM-V or ICSD-3;
  • Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency >20 min;
  • Insomnia Severity Index score ≥ 15;
  • Speak and understand English;
  • Have a smart device (phone or tablet) for mobile app installation

Exclusion Criteria:

  • Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.);
  • Shift worker or routine night shifts;
  • Women with pregnancy or breastfeeding;
  • Regular (defined as twice a week or more) practice of mind-body interventions;
  • Patients with pace-maker or routinely using cardiovascular medications that have effects on heart rates (i.e., beta-blockers);
  • Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders;
  • Currently under medications with sleep changing effects (e.g., anxiolytics/benzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.);
  • Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Instructed bedtime app-guided mindfulness meditation

Participants will utilize the specific sleep program available within the app, which will include a choice of audio soundtracks for guided MM (no exposure to screen lights during practice). The practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. Participants will specifically use the app during the immediate pre-sleep period. They can choose their preferred meditation sessions within the Sleep menu in Week 1-4.

experimental: Uninstructed app-guided mindfulness meditation

Participants will be asked to practice MM using the same app during daytime (prior to the evening meal), but without specific study instructions around components to access or specific time of practice.

other: Sleep Hygiene Education only

Participants will receive sleep hygiene education and asked not to start any new insomnia treatments. Sleep hygiene education serves as a minimal intervention control condition and real-world comparator. At the end of the study, interested participants in the control group will be given equal access to the mobile app. Usual care for insomnia typically involves sleep hygiene education, so all three groups will receive standard SHE as part of usual care.

Interventions

Instructed bedtime app-guided mindfulness meditation

All participants will access the a smartphone app, and the mindfulness meditation practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. The investigators will provide instructions for participants who are assigned to practice at bedtime.

Uninstructed app-guided mindfulness meditation

The guided mindfulness meditation practice will also be based on the same app. The investigators will not provide instructions for participants, and they have complete freedom to use the app as real-world users.

Sleep hygiene education

Sleep hygiene education will be based on recognized, general, non-personalized sleep hygiene advice, for example, recommendations about bedtime routines and use of alcohol and caffeine, tips on creating a sleep-conducive bedroom environment.

Primary outcome measure

  • Screened-to-eligible ratio [ Time Frame: Week 0 ]
  • Retention rate [ Time Frame: Weeks 4, 8, and 16 ]
  • Adherence to intervention protocol [ Time Frame: Week 4 ]
  • Compliance with outcome assessment [ Time Frame: Weeks 0, 4, 8, 16 ]
  • Acceptability [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Yan Ma

(617) 732-8544yanma@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-23.