Remote STATE Training for Insomnia in Older Adults

NCT ID: NCT06589024

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: 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.

Active Comparator

Sleep hygiene education

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type: OTHER

Access to sleep hygiene education materials

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training

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.

Intervention Type: OTHER

Sleep Hygiene Education

Access to sleep hygiene education materials

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Participants who have an Insomnia disorder diagnosis per DSM-V.

3. Participants who exhibit > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO).

4. Participants must be a US resident.

5. Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.

6. 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 Criteria

1. Participants who score ≥ 4 on the Cognitive Function Index (CFI).

2. Participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks.

3. Participants with past or present psychosis, schizophrenia, or bipolar disorder. Participants with other untreated psychiatric disorder, including substance abuse/dependence disorders.

4. Participants with a seizure disorder.

5. Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome).

6. Participants with a recent hospitalization, ongoing chemotherapy or other cancer treatment.

7. 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.

8. Participants who are using computer-based cognitive training programs or have used it within a month of the consent date.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Van Vleet, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Andrew Krystal, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Posit Science Corporation

San Francisco, California, United States

Countries

United States

Other Identifiers

PSC-0702-22

Identifier Type: -

Identifier Source: org_study_id