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| Name | Class |
|---|---|
| Advanced Medical Electronics | OTHER |
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Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep education and relaxation 1 | Active Comparator | Behavioral education intervention about sleep and relaxation |
|
| Sleep education and relaxation 2 | Experimental | Behavioral education intervention about sleep and relaxation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep education and relaxation 1 | Behavioral | Sleep hygiene and relaxation training; Sleep education and relaxation 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep onset latency | time to fall asleep | four weeks |
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Inclusion Criteria: 1) Sleep onset latency > 30 min for at least 3 nights per week
Exclusion Criteria: 1) Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19103 | United States |
At conclusion of study as per NIH guidelines
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2024 | |
| Reset | Oct 1, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2024 | Oct 1, 2024 |
| 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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| Sleep education and relaxation 2 | Behavioral | Modified sleep hygiene and relaxation training; Sleep education and relaxation 2 |
|
| D001523 |
| Mental Disorders |