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Mindfulness Meditation for Insomnia

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

Tracking Information
First Submitted Date  ICMJE January 23, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date July 22, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 24, 2020)
  • Insomnia Severity Index [ Time Frame: At baseline and at the end of 4-week program ]
    A commonly used subjective sleep measure
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mindfulness Meditation for Insomnia
Official Title  ICMJE Neurophysiological Patterns of Mindfulness Meditation for Insomnia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Insomnia
Intervention  ICMJE Behavioral: Mindfulness
Subjects practice mindfulness before bedtime
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04242771
Other Study ID Numbers  ICMJE 2019P000984
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gloria Y. Yeh, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP