Mindfulness Meditation for Insomnia

NCT04242771 | Completed

• 1 other identifier: 2019P000984
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Feasibility (i.e., subject retention at initial follow-up assessment)

  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.

  At one month follow up visit

Secondary Outcomes (1)

• Acceptability

  At completion of the 4 week program

Other Outcomes (3)

• Insomnia Severity Index

  At baseline and at the end of 4-week program

• Polysomnogram-derived sleep onset latency

  At baseline and at the end of 4-week program

• Polysomnogram-derived sleep efficiency

  At baseline and at the end of 4-week program

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Subjects practice mindfulness before bedtime

Experimental group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. age 20 - 50 years\*
• \. 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
• \. speak and understand English
• \. have a smart phone for mobile app installation

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: December 2, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)