Remote STATE Training for Insomnia in Older Adults

Last updated: January 8, 2025
Sponsor: Posit Science Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Sleep Hygiene Education

Computerized Plasticity-Based Adaptive Cognitive Training

Clinical Study ID

NCT06589024
PSC-0702-22
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants who are 65 years of age or older. The inclusion age of ≥ 65 is inaccordance with the FDA's Guideline for Industry Studies in Support of SpecialPopulations (Geriatrics ICH-E7), which uses 65 as its cutoff for defining thegeriatric 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 minuteswake after sleep onset (WASO).

  4. Participants must be a US resident.

  5. Participants who are fluent English speakers, per self-report, to ensure reasonableneuropsychological 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 normalviewing distance, auditory capacity adequate to understand normal speech, and motorcapacity adequate to control a computer mouse or a tablet.

Exclusion

Exclusion Criteria:

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

  2. Participants who self-report vision or hearing difficulties that would interferewith 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 substanceabuse/dependence disorders.

  4. Participants with a seizure disorder.

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

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

  7. Participants enrolled in a concurrent clinical trial involving an investigationalpharmaceutical, nutraceutical, medical device, or behavioral treatment (CBTi) in thelast 12-months that could affect the outcome of this study, or concurrent engagementin another insomnia treatment, per self-report. However, participation in standardtreatments not known to affect sleep (e.g., occupational therapy) or use ofprescribed medications (e.g., anti-depressants) is allowable if stable onmedications for > 3 months.

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

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Sleep Hygiene Education
Phase:
Study Start date:
January 03, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Posit Science Corporation

    San Francisco, California 94111
    United States

    Active - Recruiting

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