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Mindfulness Meditation for Insomnia

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ClinicalTrials.gov Identifier: NCT04242771
Recruitment Status : Unknown
Verified July 2020 by Gloria Y. Yeh, Beth Israel Deaconess Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : July 22, 2020
Information provided by (Responsible Party):
Gloria Y. Yeh, 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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Mindfulness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : May 1, 2021

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.

Primary Outcome Measures :
  1. Feasibility (i.e., subject retention at initial follow-up assessment) [ Time Frame: 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 :
  1. Acceptability [ Time Frame: 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:
  1. Insomnia Severity Index [ Time Frame: At baseline and at the end of 4-week program ]
    A commonly used subjective sleep measure

  2. Polysomnogram-derived sleep onset latency [ Time Frame: 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.

  3. Polysomnogram-derived sleep efficiency [ Time Frame: 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.

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
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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: January 27, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders