Brain training for better sleep: new study tests computer program for insomnia in seniors
NCT ID NCT06589024
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase II study tests whether a computerized cognitive training program can improve sleep and brain health in 240 older adults (65+) with insomnia. Participants will do brain exercises at home for about 36 minutes a day, five days a week, for 36 sessions. The study compares this to sleep hygiene education to see if the training helps people fall asleep faster and stay asleep longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- computerized cognitive training program
- What this could lead to
- If it works, this could offer a non-drug, at-home option to help older adults with insomnia sleep better and improve brain function.
- What could go wrong
- This is a phase II study, so it's still early. The training may not work for everyone, and results may not apply to all older adults with insomnia.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Posit Science Corporation
San Francisco, California, 94111, United States
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