Bedtime mindfulness meditation for chronic trouble falling asleep

A Pilot Feasibility and Acceptability RCT of an App-Based Mindfulness Meditation Intervention for Sleep Among Patients With Insomnia Disorder

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
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06972303 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Yan Ma

Conditions Sleep Initiation and Maintenance Disorders; Insomnia; Insomnia Chronic; Mindfulness; Telemedicine