Remote STATE Training for Insomnia in Older Adults

NCT06589024 | Active Not Recruiting

• 1 other identifier: PSC-0702-22
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 to improve sleep regulation and brain health and extend functional independence in older adults with insomnia.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  At 9 weeks and at 6 months

Secondary Outcomes (15)

• Wake After Sleep Onset

  At 9 weeks and at 6 months

• Sleep Onset Latency

  At 9 weeks and at 6 months

• Total Sleep Time

  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

Study Arms (2)

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.

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

ACTIVE COMPARATOR

Sleep hygiene education

Other: Sleep Hygiene Education

Interventions

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.

Experimental Treatment

Sleep Hygiene Education OTHER

Access to sleep hygiene education materials

Active Comparator

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Posit Science Corporation

San Francisco, California, 94111, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

• Andrew Krystal, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)