RecruitingPHASE1, PHASE2NCT06972303

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

Sponsor: Brigham and Women's Hospital

Trial Details

ConditionSleep Initiation and Maintenance Disorders, Insomnia, Insomnia Chronic, Mindfulness, Telemedicine
InterventionInstructed bedtime app-guided mindfulness meditation; Uninstructed app-guided mindfulness meditation; Sleep hygiene education
PhasePHASE1, PHASE2
StatusRecruiting
Participants30
Est. Completion31 July 2028
Last Updated23 June 2026

Primary Outcome

Screened-to-eligible ratio; Retention rate; Adherence to intervention protocol; Compliance with outcome assessment; Acceptability

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

United States
View Registry Entry

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