Insomnia
Conditions
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.
Interventions
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.
OTHERSleep Hygiene Education
Access to sleep hygiene education materials
Sponsors
Posit Science Corporation
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Efficiency | At 9 weeks and at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Van Vleet, PhD
Posit Science Corporation
PRINCIPAL_INVESTIGATORAndrew Krystal, MD
University of California, San Francisco
Outcome results
None listed