Remote STATE Training for Insomnia in Older Adults (rSTATE)

Posit Science

Status: Enrolling

Conditions: Insomnia

Treatments: Other: Sleep Hygiene Education; Other: Computerized Plasticity-Based Adaptive Cognitive Training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06589024

PSC-0702-22

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Experimental Treatment

Experimental group

Description:

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, \~36 minutes per session.

Treatment:

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

Active Comparator group

Description:

Sleep hygiene education

Treatment:

Other: Sleep Hygiene Education