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
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Gloria Y. Yeh, Beth Israel Deaconess Medical Center
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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 :
- 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 :
- 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:
- 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.
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