ClinicalTrials.gg
Active, not recruitingNCT06589024rSTATEUpdated Feb 10, 2026

Remote STATE Training for Insomnia in Older Adults

An interventional study of Computerized Plasticity-Based Adaptive Cognitive Training and Sleep Hygiene Education in Insomnia, sponsored by Posit Science Corporation. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States — 146 open to participants now, 183 under way, 5 of them phase 3. Sleep Initiation and Maintenance Disorders · United States.

Planned enrollment
129th of 855
240 · median 60
Started
2025
with 55 others
No phase
577 of 903
107 open now
Primary completion
2026-12
later than 48 of 182 live
Registered
770th of 903
by date

Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, this one is the 129th largest by planned enrollment of the 855 interventional ones that give a count, is one of 56 that started in 2025, is one of 577 with no phase, reaches primary completion later than 48 of the 182 other live ones, and was the 770th registered.

Sleep Initiation and Maintenance Disorders

2,728 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 730 are open to participants now.

Browse Sleep Initiation and Maintenance Disorders studies →

Open to participants now

146 of the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States are open now. Recruiting first, the newest first:

141 more — sign in →

All 146 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 389 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 207 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  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

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Experimental Treatment

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

    Other: Computerized Plasticity-Based Adaptive Cognitive Training

  • Active comparator
    Active Comparator

    Sleep hygiene education

    Other: Sleep Hygiene Education

Interventions

  • OtherComputerized Plasticity-Based Adaptive Cognitive Training

    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

06

What researchers measure

Primary outcomes

  1. Sleep Efficiency

    Time frame: At 9 weeks and at 6 months

Secondary outcomes

  1. Wake After Sleep Onset

    Time frame: At 9 weeks and at 6 months

  2. Sleep Onset Latency

    Time frame: At 9 weeks and at 6 months

  3. Total Sleep Time

    Time frame: At 9 weeks and at 6 months

  4. Total Time in Bed

    Time frame: At 9 weeks and at 6 months

  5. Total Wake Time

    Time frame: At 9 weeks and at 6 months

  6. Sleep Quality

    Evaluated using the Insomnia Severity Index (ISI).

    Time frame: At 9 weeks and at 6 months

  7. Patient Health Questionnaire - 8 questions (PHQ-8) Score

    Time frame: At 9 weeks and at 6 months

  8. Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score

    Time frame: At 9 weeks and at 6 months

  9. Percentage of Time Spent in Stage N1 Sleep

    Time frame: At 9 weeks

  10. Percentage of Time Spent in Stage N2 Sleep

    Time frame: At 9 weeks

  11. Percentage of Time Spent in Stage N3 Sleep

    Time frame: At 9 weeks

  12. Percentage of Time Spent in REM Sleep

    Time frame: At 9 weeks

  13. REM Latency

    Time frame: At 9 weeks

  14. Gradual-Onset Continuous Performance Task Score

    To measure task engagement

    Time frame: At 9 weeks and at 6 months

  15. Complex Set-Shifting Score

    To measure task engagement

    Time frame: At 9 weeks and at 6 months

07

Study locations

1 site
  • Posit Science Corporation
    San Francisco, California 94111, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.

Of 78 industry-sponsored interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 23 months is above that.

Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2024
First posted
Sep 19, 2024
StartActual
Jan 3, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Feb 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06589024
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jan 3, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Feb 10, 2026

Study contacts

Thomas Van Vleet, PhD
principal investigator · Posit Science Corporation
Andrew Krystal, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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