Computerized training program for insomnia in older adults

Remote STATE Training for Insomnia in Older Adults - Phase II

This study is testing a computer program that helps older adults with insomnia improve their sleep and brain health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Posit Science Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06589024 on ClinicalTrials.gov

What this trial studies

This study, known as rSTATE, evaluates the effectiveness of a computerized cognitive training program aimed at improving sleep regulation and brain health in older adults suffering from insomnia. The intervention includes both cognitive training and sleep hygiene education, targeting individuals aged 65 and older who meet specific insomnia criteria. By utilizing a remote format, the program seeks to enhance functional independence among participants while addressing their sleep issues.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 65 and above who have a diagnosed insomnia disorder and experience significant sleep onset latency or wake after sleep onset.

Not a fit: Patients who do not have insomnia or those who are younger than 65 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve sleep quality and overall health in older adults with insomnia.

How similar studies have performed: Previous studies have shown promise in using cognitive training for sleep disorders, suggesting that this approach may be effective.

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.

Where this trial is running

San Francisco, California

• Posit Science Corporation — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Thomas Van Vleet, PhD — Posit Science Corporation
• Study coordinator: Kathy Wannaviroj

Conditions Insomnia