search
Back to results

Mindfulness Meditation for Insomnia

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insomnia

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability
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.

Full Information

First Posted
January 23, 2020
Last Updated
January 3, 2023
Sponsor
Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04242771
Brief Title
Mindfulness Meditation for Insomnia
Official Title
Neurophysiological Patterns of Mindfulness Meditation for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Subjects practice mindfulness before bedtime
Primary Outcome Measure Information:
Title
Feasibility (i.e., subject retention at initial follow-up assessment)
Description
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.
Time Frame
At one month follow up visit
Secondary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
At completion of the 4 week program
Other Pre-specified Outcome Measures:
Title
Insomnia Severity Index
Description
A commonly used subjective sleep measure
Time Frame
At baseline and at the end of 4-week program
Title
Polysomnogram-derived sleep onset latency
Description
The amount of time it takes to fall asleep after the lights have been turned off.
Time Frame
At baseline and at the end of 4-week program
Title
Polysomnogram-derived sleep efficiency
Description
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.
Time Frame
At baseline and at the end of 4-week program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Ma
Phone
6179553419
Email
yma3@bidmc.harvard.edu
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Yeh
First Name & Middle Initial & Last Name & Degree
Gloria Yeh
First Name & Middle Initial & Last Name & Degree
Yan Ma

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mindfulness Meditation for Insomnia

We'll reach out to this number within 24 hrs