Mindfulness Meditation for Insomnia

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT04242771

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: Mindfulness	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Neurophysiological Patterns of Mindfulness Meditation for Insomnia

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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 Subjects practice mindfulness before bedtime
No Intervention: Control group Participants randomized to the waitlist control group will be asked to maintain their usual care during the one month after baseline assessment. They will be asked not to start any new treatments for their insomnia. At the end of the one-month study, they will be given access to the mobile app.

Arm

Intervention/Treatment

Experimental: Experimental group

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

Subjects practice mindfulness before bedtime

No Intervention: Control group

Participants randomized to the waitlist control group will be asked to maintain their usual care during the one month after baseline assessment. They will be asked not to start any new treatments for their insomnia. At the end of the one-month study, they will be given access to the mobile app.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Insomnia Severity Index [At baseline and at the end of 4-week program]
A commonly used subjective sleep measure
Polysomnogram-derived sleep onset latency [At baseline and at the end of 4-week program]
The amount of time it takes to fall asleep after the lights have been turned off.
Polysomnogram-derived sleep efficiency [At baseline and at the end of 4-week program]
Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. age 20 - 50 years*
1. 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
1. speak and understand English
1. 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)
1. shift worker or routine night shifts
1. women with pregnancy or breast feeding
1. history of head trauma or surgery
1. regular (defined as twice a week or more) practice of mind-body interventions
1. neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
1. current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT04242771

Other Study ID Numbers:

2019P000984

First Posted:

Jan 27, 2020

Last Update Posted:

Jul 22, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jul 22, 2020