Clinical trial NCT06589024: Remote STATE Training for Insomnia in Older Adults
Official title: Remote STATE Training for Insomnia in Older Adults - Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2024-09-19
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Efficiency
timeFrame: At 9 weeks and at 6 months
Secondary outcomes:
measure: Wake After Sleep Onset
timeFrame: At 9 weeks and at 6 months
measure: Sleep Onset Latency
timeFrame: At 9 weeks and at 6 months
measure: Total Sleep Time
timeFrame: At 9 weeks and at 6 months
measure: Total Time in Bed
timeFrame: At 9 weeks and at 6 months
measure: Total Wake Time
timeFrame: At 9 weeks and at 6 months
measure: Sleep Quality
timeFrame: At 9 weeks and at 6 months
measure: Patient Health Questionnaire - 8 questions (PHQ-8) Score
timeFrame: At 9 weeks and at 6 months
measure: Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score
timeFrame: At 9 weeks and at 6 months
measure: Percentage of Time Spent in Stage N1 Sleep
timeFrame: At 9 weeks
measure: Percentage of Time Spent in Stage N2 Sleep
timeFrame: At 9 weeks
measure: Percentage of Time Spent in Stage N3 Sleep
timeFrame: At 9 weeks
measure: Percentage of Time Spent in REM Sleep
timeFrame: At 9 weeks
measure: REM Latency
timeFrame: At 9 weeks
measure: Gradual-Onset Continuous Performance Task Score
timeFrame: At 9 weeks and at 6 months
measure: Complex Set-Shifting Score
timeFrame: At 9 weeks and at 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Posit Science Corporation
state: California
Study officials:
affiliation: Posit Science Corporation
name: Thomas Van Vleet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Andrew Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References: