Remote STATE Training for Insomnia in Older Adults

Description

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 Overview

Study Details

Study overview

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.

Remote STATE Training for Insomnia in Older Adults - Phase II

Remote STATE Training for Insomnia in Older Adults

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

San Francisco

Posit Science Corporation, San Francisco, California, United States, 94111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Posit Science Corporation,

Thomas Van Vleet, PhD, PRINCIPAL_INVESTIGATOR, Posit Science Corporation

Andrew Krystal, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-04-30