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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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This study called rSTATE (Remote STATE Training for Insomnia in Older Adults) is a Phase II study to definitively evaluate the efficacy of a computerized cognitive training program (rSTATE) designed to improve sleep regulation and brain health and extend functional independence in older adults with insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, ~36 minutes per session. |
|
| Active Comparator | Active Comparator | Sleep hygiene education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive Training | Other | Training on computerized exercises that targets processing speed, attention and executive function for about 36 minutes per session, 5 sessions per week for a total of 36 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | At 9 weeks and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wake After Sleep Onset | At 9 weeks and at 6 months | |
| Sleep Onset Latency | At 9 weeks and at 6 months | |
| Total Sleep Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Van Vleet, PhD | Posit Science Corporation | Principal Investigator |
| Andrew Krystal, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Posit Science Corporation | San Francisco | California | 94111 | 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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| Sleep Hygiene Education | Other | Access to sleep hygiene education materials |
|
| At 9 weeks and at 6 months |
| Total Time in Bed | At 9 weeks and at 6 months |
| Total Wake Time | At 9 weeks and at 6 months |
| Sleep Quality | Evaluated using the Insomnia Severity Index (ISI). | At 9 weeks and at 6 months |
| Patient Health Questionnaire - 8 questions (PHQ-8) Score | At 9 weeks and at 6 months |
| Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score | At 9 weeks and at 6 months |
| Percentage of Time Spent in Stage N1 Sleep | At 9 weeks |
| Percentage of Time Spent in Stage N2 Sleep | At 9 weeks |
| Percentage of Time Spent in Stage N3 Sleep | At 9 weeks |
| Percentage of Time Spent in REM Sleep | At 9 weeks |
| REM Latency | At 9 weeks |
| Gradual-Onset Continuous Performance Task Score | To measure task engagement | At 9 weeks and at 6 months |
| Complex Set-Shifting Score | To measure task engagement | At 9 weeks and at 6 months |
| D001523 |
| Mental Disorders |