Mindfulness Meditation for Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Mindfulness

• Registration Number: NCT04242771
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-27
• Study Start: 2022-12-02
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• 1. age 20 - 50 years*
• 2. chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency >20 minutes
• 3. speak and understand English
• 4. have a smart phone for mobile app installation

Exclusion Criteria

• 1. sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
• 2. shift worker or routine night shifts
• 3. women with pregnancy or breast feeding
• 4. history of head trauma or surgery
• 5. regular (defined as twice a week or more) practice of mind-body interventions
• 6. neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
• 7. current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Mindfulness	Participants will utilize a daily sleep program available within a widely used smartphone app, which includes seven soundtracks (10-15min each) for guided mindfulness practice at bedtime. Techniques include breathing exercises, mental imagery, awareness of body and mind, and muscle and body relaxation.

Primary Outcome Measures

Name	Time	Method
Feasibility (i.e., subject retention at initial follow-up assessment)	At one month follow up visit	The primary metric for assessing Feasibility will be subject retention at the initial follow-up assessment. This includes the proportion of enrolled subjects that are active in the study at the initial follow-up assessment.

Secondary Outcome Measures

Name	Time	Method
Acceptability	At completion of the 4 week program	The primary metric for assessing Acceptability will be a self-report Acceptability questionnaire which evaluates enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the program.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States