Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Andrew Krystal, MD
Headshot of Andrew Krystal
Andrew Krystal

Description

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.

Official Title

Remote STATE Training for Insomnia in Older Adults - Phase II

Keywords

Insomnia, Sleep Initiation and Maintenance Disorders, Computerized Plasticity-Based Adaptive Cognitive Training, Sleep Hygiene Education

Eligibility

You can join if…

Open to people ages 65 years and up

  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.

You CAN'T join if...

  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.

Location

  • Posit Science Corporation
    San Francisco California 94111 United States

Lead Scientist at UCSF

  • Andrew Krystal, MD
    Dr. Krystal is the Ray and Dagmar Dolby Distinguished Professor in the Departments of Psychiatry and Neurology, Vice-Chair for Research in the Department of Psychiatry, Director of the Dolby Family Center for Mood Disorders, Director of the UCSF Interventional Psychiatry Program and Co-Director of the TMS & Neuromodulation Clinic.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Posit Science Corporation
ID
NCT06589024
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated