Remote STATE Training for Insomnia in Older Adults (rSTATE)

Remote STATE Training for Insomnia in Older Adults - Phase II

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia
• Intervention / Treatment: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Sleep Hygiene Education

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: Active Comparator; Sleep hygiene education	Other: Sleep Hygiene Education; Access to sleep hygiene education materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sleep Efficiency	At 9 weeks and at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time		At 9 weeks and at 6 months
Wake After Sleep Onset		At 9 weeks and at 6 months
Sleep Onset Latency		At 9 weeks and at 6 months
Total Time in Bed		At 9 weeks and at 6 months
Total Wake Time		At 9 weeks and at 6 months
Sleep Quality	Evaluated using the Insomnia Severity Index (ISI).	At 9 weeks and at 6 months
Patient Health Questionnaire - 8 questions (PHQ-8) Score		At 9 weeks and at 6 months
Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score		At 9 weeks and at 6 months
Percentage of Time Spent in Stage N1 Sleep		At 9 weeks
Percentage of Time Spent in Stage N2 Sleep		At 9 weeks
Percentage of Time Spent in Stage N3 Sleep		At 9 weeks
Percentage of Time Spent in REM Sleep		At 9 weeks
REM Latency		At 9 weeks
Gradual-Onset Continuous Performance Task Score	To measure task engagement	At 9 weeks and at 6 months
Complex Set-Shifting Score	To measure task engagement	At 9 weeks and at 6 months

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Andrew Krystal, MD, University of California, San Francisco; Principal Investigator: Thomas Van Vleet, PhD, Posit Science Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: PSC-0702-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No