InsomniarSTATENCT06589024
Remote STATE Training for Insomnia in Older Adults
A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Sleep Hygiene Education in people with Insomnia, run by Posit Science Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Computerized Plasticity-Based Adaptive Cognitive Training and Sleep Hygiene Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
- Participants who have an Insomnia disorder diagnosis per DSM-V.
- Participants who exhibit > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO).
- Participants must be a US resident.
- Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
- 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.
Who cannot join
- Participants who score ≥ 4 on the Cognitive Function Index (CFI).
- Participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks.
- Participants with past or present psychosis, schizophrenia, or bipolar disorder. Participants with other untreated psychiatric disorder, including substance abuse/dependence disorders.
- Participants with a seizure disorder.
- Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome).
- Participants with a recent hospitalization, ongoing chemotherapy or other cancer treatment.
- 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.
- Participants who are using computer-based cognitive training programs or have used it within a month of the consent date.
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94111
About this study
Official title: Remote STATE Training for Insomnia in Older Adults - Phase II
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.
- Conditions
- Insomnia
- Being tested
- Computerized Plasticity-Based Adaptive Cognitive Training, Sleep Hygiene Education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-Based Adaptive Cognitive TrainingOther
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.
Sleep Hygiene EducationOther
Access to sleep hygiene education materials
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, ~36 minutes per session. Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training |
| Active Comparator | Active comparator | Sleep hygiene education Receives: Other: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Measured: At 9 weeks and at 6 months
Secondary outcomes (15)
Wake After Sleep Onset
Measured: At 9 weeks and at 6 months
Sleep Onset Latency
Measured: At 9 weeks and at 6 months
Total Sleep Time
Measured: At 9 weeks and at 6 months
Total Time in Bed
Measured: At 9 weeks and at 6 months
Total Wake Time
Measured: At 9 weeks and at 6 months
Sleep Quality
Evaluated using the Insomnia Severity Index (ISI).
Measured: At 9 weeks and at 6 months
Patient Health Questionnaire - 8 questions (PHQ-8) Score
Measured: At 9 weeks and at 6 months
Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score
Measured: At 9 weeks and at 6 months
Percentage of Time Spent in Stage N1 Sleep
Measured: At 9 weeks
Percentage of Time Spent in Stage N2 Sleep
Measured: At 9 weeks
Percentage of Time Spent in Stage N3 Sleep
Measured: At 9 weeks
Percentage of Time Spent in REM Sleep
Measured: At 9 weeks
REM Latency
Measured: At 9 weeks
Gradual-Onset Continuous Performance Task Score
To measure task engagement
Measured: At 9 weeks and at 6 months
Complex Set-Shifting Score
To measure task engagement
Measured: At 9 weeks and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Thomas Van Vleet, PhD, Principal investigator, Posit Science CorporationAndrew Krystal, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589024
- Sponsor's protocol ID
- PSC-0702-22
- Acronym
- rSTATE
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote STATE Training for Insomnia in Older Adults - Phase II
- ClinicalTrials.gov ID
- NCT06589024
- Acronym / sponsor ID
- rSTATE / PSC-0702-22
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive TrainingComputerized 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 | Active comparator | Other: Sleep Hygiene EducationSleep hygiene education |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
- Participants who have an Insomnia disorder diagnosis per DSM-V.
- Participants who exhibit > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO).
- Participants must be a US resident.
- Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
Key exclusion criteria (8 listed)
- Participants who score ≥ 4 on the Cognitive Function Index (CFI).
- Participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks.
- Participants with past or present psychosis, schizophrenia, or bipolar disorder. Participants with other untreated psychiatric disorder, including substance abuse/dependence disorders.
- Participants with a seizure disorder.
- Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingTraining 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. | Other | Experimental Treatment |
| Sleep Hygiene EducationAccess to sleep hygiene education materials | Other | Active Comparator |
Primary outcome
Sleep Efficiency
Time frame: At 9 weeks and at 6 months
15 secondary outcomes
Wake After Sleep Onset
Time frame: At 9 weeks and at 6 months
Sleep Onset Latency
Time frame: At 9 weeks and at 6 months
Total Sleep Time
Time frame: At 9 weeks and at 6 months
Total Time in Bed
Time frame: At 9 weeks and at 6 months
Total Wake Time
Time frame: At 9 weeks and at 6 months
Sleep Quality
Time frame: At 9 weeks and at 6 months
Patient Health Questionnaire - 8 questions (PHQ-8) Score
Time frame: At 9 weeks and at 6 months
Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score
Time frame: At 9 weeks and at 6 months
Percentage of Time Spent in Stage N1 Sleep
Time frame: At 9 weeks
Percentage of Time Spent in Stage N2 Sleep
Time frame: At 9 weeks
Percentage of Time Spent in Stage N3 Sleep
Time frame: At 9 weeks
Percentage of Time Spent in REM Sleep
Time frame: At 9 weeks
REM Latency
Time frame: At 9 weeks
Gradual-Onset Continuous Performance Task Score
Time frame: At 9 weeks and at 6 months
Complex Set-Shifting Score
Time frame: At 9 weeks and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Van Vleet, PhD principal investigator
Posit Science Corporation
Andrew Krystal, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Sleep Hygiene Education in people with Insomnia, run by Posit Science Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: At 9 weeks and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.