Status:
RECRUITING
Remote STATE Training for Insomnia in Older Adults
Lead Sponsor:
Posit Science Corporation
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Insomnia
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Participants who are 65 years of age or older. The inclusion age of ≥ 65 is in accordance with the FDA's Guideline for Industry Studies in Support of Special Populations (Geriatrics ICH-E7), which uses 65 as its cutoff for defining the geriatric population prone to insomnia.
- Participants who have an Insomnia disorder diagnosis per DSM-V.
- Participants who exhibit \> 30 minutes sleep onset latency (SOL); and/or \> 30 minutes wake after sleep onset (WASO).
- Participants must be a US resident.
- Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
- Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet.
Exclusion
- Participants who score ≥ 4 on the Cognitive Function Index (CFI).
- Participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks.
- Participants with past or present psychosis, schizophrenia, or bipolar disorder. Participants with other untreated psychiatric disorder, including substance abuse/dependence disorders.
- Participants with a seizure disorder.
- Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome).
- Participants with a recent hospitalization, ongoing chemotherapy or other cancer treatment.
- Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment (CBTi) in the last 12-months that could affect the outcome of this study, or concurrent engagement in another insomnia treatment, per self-report. However, participation in standard treatments not known to affect sleep (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable if stable on medications for \> 3 months.
- Participants who are using computer-based cognitive training programs or have used it within a month of the consent date.
Key Trial Info
Start Date :
January 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06589024
Start Date
January 3 2025
End Date
June 30 2026
Last Update
September 5 2025
Active Locations (1)
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1
Posit Science Corporation
San Francisco, California, United States, 94111