Remote STATE Training for Insomnia in Older Adults

Not Applicable

Recruiting

• Conditions: Insomnia
• Interventions: Other: Computerized Plasticity-Based Adaptive Cognitive Training; Other: Sleep Hygiene Education

• Registration Number: NCT06589024
• Lead Sponsor: Posit Science Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Study Start: 2025-01-03
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Treatment	Computerized Plasticity-Based Adaptive Cognitive Training	Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, \~36 minutes per session.
Active Comparator	Sleep Hygiene Education	Sleep hygiene education

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency	At 9 weeks and at 6 months

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	At 9 weeks and at 6 months	Evaluated using the Insomnia Severity Index (ISI).
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	At 9 weeks and at 6 months	To measure task engagement
Complex Set-Shifting Score	At 9 weeks and at 6 months	To measure task engagement
Wake After Sleep Onset	At 9 weeks and at 6 months
Sleep Onset Latency	At 9 weeks and at 6 months
Total Sleep Time	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

Trial Locations

Locations (1)

Posit Science Corporation; 🇺🇸 San Francisco, California, United States