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Active, Not Recruiting

NCT Number: NCT06589024

Remote STATE Training for Insomnia in Older Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Posit Science Corporation

San Francisco, California, 94111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

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 education

Other

Access to sleep hygiene education materials

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

    Time frame: At 9 weeks and at 6 months

    Evaluated using the Insomnia Severity Index (ISI).

  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

    Time frame: At 9 weeks and at 6 months

    To measure task engagement

  15. Complex Set-Shifting Score

    Time frame: At 9 weeks and at 6 months

    To measure task engagement

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Remote STATE Training for Insomnia in Older Adults - Phase II

Acronym: rSTATE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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