Remote STATE Training for Insomnia in Older Adults - Phase II

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 to improve sleep regulation and brain health and extend functional independence in older adults with insomnia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
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• 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.

Locations
United States
California
Posit Science Corporation
RECRUITING
San Francisco
Contact Information
Primary
Kathy Wannaviroj
rstate@brainhq.com
(415) 568-3565
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 240
Treatments
Experimental: Experimental Treatment
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
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Francisco
Leads: Posit Science Corporation

This content was sourced from clinicaltrials.gov