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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 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.

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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.

Conditions Studied

Insomnia Sleep Initiation and Maintenance Disorders Telemedicine Insomnia Chronic Mindfulness

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

FieldValue
Enrollment Target 30 participants
Start Date 2026-02
Est. Completion 2028-12-29
Phase Phase 1

Sponsor

Brigham and Women's Hospital

937 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06972303

The ClinicalTrials.gov registry entry for NCT06972303 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (82% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.