Remote Cognitive Training for Insomnia

(rSTATE Trial)

Overseen By Kathy Wannaviroj

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Posit Science Corporation

Disqualifiers: Psychosis, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a computerized brain training program, known as Computerized Plasticity-Based Adaptive Cognitive Training, to improve sleep and brain health in older adults with insomnia. Participants will either receive this new treatment or learn about good sleep habits. It suits those aged 65 and older who struggle to fall asleep or stay asleep for more than 30 minutes. Participants must be able to use a computer and understand English. Those with untreated sleep apnea, ongoing mental health issues, or recent hospitalizations may not qualify for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to enhancing sleep and brain health.

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 prior data suggests that this computerized cognitive training program is safe for older adults with insomnia?

Studies have shown that computerized brain training programs, like the one tested in the rSTATE trial, are generally safe and easy to use. Participants in similar programs have not reported any serious side effects. These programs are non-invasive, meaning they don't involve surgery or entering the body.

Previous research indicates that people using these digital brain tools experienced improvements in sleep and mental function without major negative effects. No reports of harm or significant discomfort emerged during the studies. This suggests that the computerized training in this trial should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for insomnia, which often include medications and cognitive behavioral therapy (CBT), this new approach uses computerized plasticity-based adaptive cognitive training. This method provides a personalized training experience that adapts to the user's cognitive needs, potentially enhancing brain plasticity and improving sleep patterns. Researchers are excited because this innovative approach could offer a non-pharmacological, engaging, and flexible treatment option that users can access remotely, making it more convenient and accessible for many people.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that special computer-based brain training, which participants in this trial may receive as part of the experimental treatment arm, can help improve sleep in older adults with insomnia. One clinical trial found that this training led to significant and lasting improvements in thinking skills, which may help regulate sleep. This training reduces the mental effort needed in the brain's front part, leading to better performance and possibly better sleep. Additionally, these programs have enhanced how quickly individuals process information, remember things, and make decisions, all of which may help improve sleep quality. Overall, early findings suggest that this training could be a promising way to address insomnia. ^{1 4 6 7 8}

Who Is on the Research Team?

Andrew Krystal, MD, MS

Principal Investigator

University of California, San Francisco

Thomas Van Vleet, PhD

Principal Investigator

Posit Science Corporation

Are You a Good Fit for This Trial?

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 must be a US resident

Participants who are fluent English speakers to ensure reasonable neuropsychological results on key assessments

I am 65 years old or older.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Plasticity-Based Adaptive Cognitive Training
• Sleep Hygiene Education

Trial Overview The 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.

How Is the Trial Designed?

Group I: Experimental Treatment Experimental Treatment 1 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 Comparator Active Control 1 Intervention

Sleep hygiene education

Who Is Running the Clinical Trial?

Posit Science Corporation

Lead Sponsor

Trials

40

Recruited

4,400+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The Sleep Scholar intervention, a self-guided online program for insomnia, was found to be feasible and acceptable among college students with a history of suicidal ideation and insomnia symptoms, with 38 participants completing the study.

Participants reported positive satisfaction with the program, and post-treatment analyses indicated clinically significant reductions in mental health symptoms, suggesting potential benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of sleep scholar: A single-session, internet-based insomnia intervention for college students with a history of suicide ideation. Crosby Ms Msw, ES., Witte PhD, TK.[2023]

An eight-week personalized computerized cognitive training program significantly improved sleep quality and cognitive performance in older adults with insomnia, as shown by a study involving 51 participants.

Improvements in cognitive skills, such as visual scanning and naming, were linked to better sleep outcomes, indicating that engaging in new learning can help enhance both sleep initiation and maintenance in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training improves sleep quality and cognitive function among older adults with insomnia. Haimov, I., Shatil, E.[2022]

A proposed clinical trial will assess a cognitive stimulation intervention for insomnia, involving 60 participants aged 25 to 55, over 8 weeks with 5 training sessions per week, aiming to evaluate safety and effectiveness.

The study will compare the cognitive training group to a control group engaged in non-cognitive activities, measuring various outcomes related to sleep, cognition, and quality of life, which could lead to new complementary therapies for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Protocol for a Randomized Controlled Trial Assessing the Effectiveness of Personalized Computerized Cognitive Training for Individuals With Insomnia. Tapia, JL., Puertas, FJ., Duñabeitia, JA.[2022]

In a pilot study involving 14 participants (7 with primary insomnia and 7 healthy controls), patients with insomnia showed significantly less improvement in procedural memory tasks after sleep compared to healthy individuals, indicating potential memory consolidation issues.

While both groups improved their performance on a mirror tracing task after sleep, healthy controls improved by 42.8%, whereas those with insomnia only improved by 20.4%, suggesting that sleep may not effectively support memory consolidation in insomnia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired sleep-related memory consolidation in primary insomnia--a pilot study. Nissen, C., Kloepfer, C., Nofzinger, EA., et al.[2019]

A study involving 100 active duty US Army personnel found that both in-person and Internet-delivered cognitive behavioral therapy for insomnia (CBTi) significantly improved sleep efficiency and reduced insomnia symptoms compared to a minimal contact control condition.

In-person CBTi was more effective than Internet CBTi in improving self-reported sleep quality and reducing dysfunctional beliefs about sleep, suggesting that while both formats are beneficial, face-to-face treatment may offer additional advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet and In-Person Cognitive Behavioral Therapy for Insomnia in Military Personnel: A Randomized Clinical Trial. Taylor, DJ., Peterson, AL., Pruiksma, KE., et al.[2022]

The Glasgow Content of Thoughts Inventory (GCTI) is a newly developed self-report measure that effectively assesses pre-sleep cognitive activity in adults with sleep-onset insomnia, demonstrating strong construct validity and reliability.

In a study involving 58 participants (29 with insomnia and 29 good sleepers), the GCTI successfully distinguished between the two groups and showed high sensitivity (100%) and good specificity (83%) for identifying sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary validation of the Glasgow Content of Thoughts Inventory (GCTI): a new measure for the assessment of pre-sleep cognitive activity. Harvey, KJ., Espie, CA.[2019]

In a study involving 270 participants at a Fortune 500 company, digital cognitive behavioral therapy (dCBT) significantly improved sleep quality, with a large effect size (Cohen's d of 1.10) compared to a waiting list group.

Participants who underwent dCBT also showed notable improvements in work productivity, particularly in reducing presenteeism, indicating that better sleep can enhance workplace performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and Productivity Benefits of Digital Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Trial Conducted in the Workplace Environment. Bostock, S., Luik, AI., Espie, CA.[2022]

Training with a complex cognitive task before bedtime significantly improved sleep quality in 20 habitual bad sleepers, leading to more organized sleep with fewer disruptions compared to baseline sleep.

The cognitive training resulted in better sleep continuity and stability, suggesting that this approach could be a valuable addition to standard treatments for sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of complex cognitive training on subsequent night sleep. Cerasuolo, M., Conte, F., Cellini, N., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8370402/

A randomized clinical trial of plasticity-based cognitive training ... A self-administered computerized cognitive training program drove significant and enduring improvements in cognitive function in people with a history of mild ...

2. clinicaltrials.gov clinicaltrials.gov/study/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 ...

3. mdpi.com mdpi.com/2077-0383/14/7/2265

Digital and AI-Enhanced Cognitive Behavioral Therapy for ... Results: The findings suggest that digital and AI-enhanced CBT significantly improves sleep parameters, patient adherence, satisfaction, and the personalization ...

4. nature.com nature.com/articles/s41598-020-72281-3

The use of commercial computerised cognitive games in ... We showed that cognitive training using commercially available ccCG is effective in improving processing speed, working memory, and executive ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S107158192300215X

Adaptative computerized cognitive training decreases ... The analyses showed a decreased mental workload within the dorsolateral prefrontal cortex and that participants considerably increased their performance in the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36992590/

Assessing the Effectiveness of a Computerized Home- ... In the current study, we report the results of Phase 1 and Phase 2 clinical trials of a home-based computerized cognitive stimulation program.

7. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-9-2024-c1d24

Remote Cognitive Training for Insomnia (rSTATE Trial) The study will compare the cognitive training group to a control group engaged in non-cognitive activities, measuring various outcomes related to sleep, ...

8. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06589024

Remote STATE Training for Insomnia in Older Adults A Phase II study to definitively evaluate the efficacy of a computerized cognitive training program (rSTATE) designed to improve sleep regulation and brain ...