Insomnia
Conditions
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.
Interventions
BEHAVIORALMindfulness
Subjects practice mindfulness before bedtime
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (i.e., subject retention at initial follow-up assessment) | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | At baseline and at the end of 4-week program | A commonly used subjective sleep measure |
| Polysomnogram-derived sleep onset latency | 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 | 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. |
Countries
United States
Outcome results
None listed