Bedtime mindfulness meditation for chronic trouble falling asleep
Official title: A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder
Run by Brigham and Women's Hospital · NCT06972303 · Data updated 2026-11-12
This pilot will test whether a 4-week bedtime mindfulness app helps adults with chronic trouble falling asleep compared with an unguided meditation app or sleep hygiene education.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | December 29, 2028 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT06972303 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with chronic sleep-onset insomnia (≥3 nights/week for ≥3 months), an Insomnia Severity Index score ≥15, English-speaking, and owning a smartphone are the intended participants.
✕Probably not a fit
People with other primary sleep disorders, regular mindfulness practice (≥2×/week), pacemakers or routine beta-blocker use, routine night-shift work, pregnancy/breastfeeding, or major neurological disorders are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This small randomized pilot (N=30) will allocate participants 1:1:1 to 4 weeks of instructed bedtime app-guided mindfulness, uninstructed app-guided mindfulness, or sleep hygiene education. The main aims are to test feasibility and acceptability of the interventions and study procedures and to explore within-group changes in insomnia severity and sleep quality. Patient-reported outcomes will be collected via REDCap at baseline and at 4, 8, and 16 weeks; participants also receive wearable devices and complete a post-intervention interview at week 4 and an exit interview at week 16. Results will be used to refine the protocol and power larger confirmatory trials.
Why it matters
Potential benefit: If successful, this could offer a brief, low-cost app-based bedtime mindfulness option that reduces time to fall asleep and improves insomnia symptoms.
How similar studies have gone: Previous randomized trials of mindfulness-based approaches have shown modest improvements in insomnia and sleep quality, but brief app-guided bedtime-specific protocols are less well tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Yan Ma
- Email: yanma@bwh.harvard.edu
- Phone: (617) 732-8544
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.