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This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.
This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral approach 1 | Experimental | This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention. |
|
| Behavioral approach 2 | Active Comparator | This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Behavioral approach 1 | Behavioral | Includes changing sleep habits and cognitions around sleep from a mental level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Pill Dosage | We will monitor changes in participants' sleep pill total dosage taken over one week using the sleep diary (which includes a daily question regarding sleeping pills used that night). The usage reduction will be calculated as a percent (total weekly usage at end of study divided by total weekly usage during the baseline week). | 28-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28). | 28-day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex J Mathew | Contact | 215-596-9715 | alex.mathew@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania School of Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | 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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| Comparator: Behavioral approach 2 | Behavioral | Includes changing sleep habits and awarenes of sleep from a perception level |
|
| D001523 |
| Mental Disorders |