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NCT06972303 · ClinicalTrials.gov registry record · Phase 1
Mindfulness Meditation for Insomnia
A Phase 1 study of Insomnia and Sleep Initiation and Maintenance Disorders, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06972303: Recruiting Phase 1 study of Insomnia and Sleep Initiation and Maintenance Disorders, sponsored by Brigham and Women's Hospital.
NCT06972303 is a Phase 1 study of Insomnia and Sleep Initiation and Maintenance Disorders that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06972303, a Phase 1 study of Insomnia and Sleep Initiation and Maintenance Disorders, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The proportion of screened participants who were determined to be eligible for the study; calculated as the number of eligible participants divided by the total number of individuals screened.
Conditions Studied
Interventions
- BEHAVIORAL Instructed bedtime app-guided mindfulness meditation
- BEHAVIORAL Uninstructed app-guided mindfulness meditation
- BEHAVIORAL Sleep hygiene education
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-02 |
| Est. Completion | 2028-12-29 |
| Phase | Phase 1 |
What NCT06972303 shows while recruiting
NCT06972303 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (82% lower).
The record links to 5 conditions, with Insomnia appearing as the primary indexed condition, and to 3 interventions - of which Instructed bedtime app-guided mindfulness meditation is the first listed.
NCT06972303 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06972303 about?
NCT06972303 is a clinical study titled "Mindfulness Meditation for Insomnia". 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 o...
What is the current status of trial NCT06972303?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-02. Estimated completion is 2028-12-29.
What conditions does trial NCT06972303 study?
This clinical trial studies the following conditions: Insomnia, Sleep Initiation and Maintenance Disorders, Telemedicine, Insomnia Chronic, Mindfulness.
What interventions are being tested in trial NCT06972303?
The interventions under investigation include: Instructed bedtime app-guided mindfulness meditation (BEHAVIORAL), Uninstructed app-guided mindfulness meditation (BEHAVIORAL), Sleep hygiene education (BEHAVIORAL).
Who is sponsoring clinical trial NCT06972303?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06972303 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06972303's enrollment target sits among peer trials
30 122nd of 151 higher than 25 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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