Remote Cognitive Training for Insomnia
(rSTATE Trial)
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Posit Science Corporation
Disqualifiers: Psychosis, Schizophrenia, Bipolar, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications as long as you have been stable on them for more than 3 months. However, you cannot be part of another clinical trial or insomnia treatment at the same time.
What data supports the effectiveness of the treatment Computerized Plasticity-Based Adaptive Cognitive Training for insomnia?
Is remote cognitive training for insomnia safe for humans?
How is the treatment 'Computerized Plasticity-Based Adaptive Cognitive Training' unique for insomnia?
Eligibility Criteria
This trial is for older adults who are experiencing insomnia. Participants should be interested in trying a computerized cognitive training program to improve their sleep and brain health, with the goal of maintaining independence.Inclusion Criteria
Participants who are fluent English speakers to ensure reasonable neuropsychological results on key assessments
Participants must be a US resident
I am 65 years old or older.
See 3 more
Exclusion Criteria
I have a seizure disorder.
Participants with a Cognitive Function Index (CFI) score ≥4
Participants with vision or hearing difficulties that would interfere with the ability to complete the study tasks
See 5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo computerized plasticity-based adaptive cognitive training with a maximum of 36 sessions, up to 5 sessions per week, approximately 36 minutes per session
9 weeks
Follow-up
Participants are monitored for sleep quality and task engagement using the Insomnia Severity Index and performance tasks
6 months
Treatment Details
Interventions
- Computerized Plasticity-Based Adaptive Cognitive Training (Behavioural Intervention)
- Sleep Hygiene Education (Other)
Trial OverviewThe study is testing rSTATE, a computerized cognitive training designed to help regulate sleep patterns in older adults with insomnia. It also includes education on good sleep practices. The effectiveness of this program will be compared against standard treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental TreatmentExperimental Treatment1 Intervention
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, \~36 minutes per session.
Group II: Active ComparatorActive Control1 Intervention
Sleep hygiene education
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Posit Science CorporationSan Francisco, CA
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Who Is Running the Clinical Trial?
Posit Science CorporationLead Sponsor
University of California, San FranciscoCollaborator
References
Cognitive training improves sleep quality and cognitive function among older adults with insomnia. [2022]To investigate the effect of an eight-week, home-based, personalized, computerized cognitive training program on sleep quality and cognitive performance among older adults with insomnia.
Sleep and Productivity Benefits of Digital Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Trial Conducted in the Workplace Environment. [2022]Evaluating digital cognitive behavioral therapy (dCBT) for insomnia in a workplace environment.
Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel: A Randomized Clinical Trial. [2022]Compare in-person and unguided Internet-delivered cognitive behavioral therapy for insomnia (CBTi) with a minimal contact control condition in military personnel.
Development and preliminary validation of the Glasgow Content of Thoughts Inventory (GCTI): a new measure for the assessment of pre-sleep cognitive activity. [2019]To develop a self-report measure (the Glasgow Content of Thoughts Inventory [GCTI]) for the assessment of pre-sleep cognitive activity in adults with sleep-onset insomnia.
A pilot study of sleep scholar: A single-session, internet-based insomnia intervention for college students with a history of suicide ideation. [2023]Establish the feasibility and acceptability of Sleep Scholar, a single-session, self-guided, internet-based insomnia intervention.
Study Protocol for a Randomized Controlled Trial Assessing the Effectiveness of Personalized Computerized Cognitive Training for Individuals With Insomnia. [2022]Insomnia is a frequent and heightened pathology in the general population of developed countries, and its condition generally leads to health discomfort and performance drop in daily and work-related tasks. As current pharmacological treatments for insomnia do not always seem sufficient to mitigate impairment, contemporary cognitive approaches might shed light on developing complementary therapies for this population. We propose a cognitive stimulation intervention program based on the importance of cognitive abilities as precipitating and maintenance variables of sleep disturbances. A full phase I-II-III clinical trial is proposed in which the first two studies will serve to assess the safety of the intervention and to identify the maximum tolerated time of the computerized cognitive training (phase I) and the minimum effective number of training sessions (phase II) in the absence of adverse events or side effects. Next, a phase-III double-blind randomized controlled trial design will be set. Sixty individuals with insomnia aged 25 to 55 years will enroll in a home-based personalized computerized cognitive stimulation program for a total time of 8 weeks, training 5 days per week. Sixty insomnia patients matched in a variety of factors will constitute the active control group, where the orthogonal activities will not be cognitively demanding. Sleep, cognitive, emotional, and quality of life variables will be measured before and immediately after training. A linear mixed model and hierarchical regression analysis will be used to investigate intervention effects. The results derived from this study will be precious for future research and treatment in cognitive performance and clinical pathologies. Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT05050292].
Impaired sleep-related memory consolidation in primary insomnia--a pilot study. [2019]To compare sleep-related consolidation of procedural memory in patients with primary insomnia and healthy controls.
The effect of complex cognitive training on subsequent night sleep. [2021]Using a nap design, we have recently shown that training at a complex cognitive task at bedtime improves objective sleep quality by reducing sleep fragmentation. In order to extend our findings to nighttime sleep, here we assess the impact of a multi-componential cognitive task at bedtime on the subsequent sleep episode of subjects reporting habitual bad sleep, allegedly characterized by high sleep fragmentation. In a within-subjects design, 20 subjective bad sleepers underwent polysomnographic recording in three conditions: (a) baseline sleep (BL); (b) post-training sleep (TR), preceded by a complex ecological task, i.e. a modified version of the word game Ruzzle; (c) post-active control sleep (AC), preceded by a control task. Sleep in TR was more organized (higher number of cycles and longer time spent in cycles) and showed lower microarousal frequency than in AC and BL. As for sleep continuity (total and brief awakening frequency) and other stability measures (state transition and functional uncertainty period frequency, time in functional uncertainty), both TR and AC showed significant improvements compared with BL. Arousal frequency was also reduced in TR relative to BL. Our results show a clear impact of cognitive training on subsequent night sleep, basically consisting of an increase in sleep continuity, stability and organization. In our sample of bad sleepers, these post-training changes end up representing a notable sleep improvement, also consistently reflected in subjective sleep quality perception. Therefore, ecological pre-sleep cognitive training should be further studied as an easily accessible complementary approach in standard therapies for sleep-disordered populations.