Mindfulness Meditation for Insomnia

NCT ID: NCT04242771

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-02

Study Completion Date

2023-08-01

Brief Summary

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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

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Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Subjects practice mindfulness before bedtime

Interventions

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Mindfulness

Subjects practice mindfulness before bedtime

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Gloria Y. Yeh

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2019P000984

Identifier Type: -

Identifier Source: org_study_id

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