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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | Subjects practice mindfulness before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At one month follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At completion of the 4 week program |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | A commonly used subjective sleep measure | At baseline and at the end of 4-week program |
| Polysomnogram-derived sleep onset latency | The amount of time it takes to fall asleep after the lights have been turned off. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| At baseline and at the end of 4-week program |
| Polysomnogram-derived sleep efficiency | 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. | At baseline and at the end of 4-week program |
| D001523 |
| Mental Disorders |