Cognitive Training for Autism and Insomnia

Overseen By Susan S Rodriguez, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Psychotropics, Beta-blockers

Disqualifiers: Sleep apnea, Bipolar, Seizure, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new cognitive training program called COGMUSE to help autistic adults who also suffer from insomnia. Participants will engage in this training from home for 60 minutes, three times a week, over six weeks, while tracking their sleep with diaries and a special watch-like device. The goal is to determine if the program is usable and effective in improving sleep. This trial suits adults diagnosed with autism who have struggled with insomnia for at least six months, particularly those who find it hard to fall asleep or stay asleep. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve sleep for many in the future.

Do I need to stop taking my current medications for this trial?

The trial requires that participants have not used sleep medications for at least one month or have been stable on their medications for six weeks. If you are taking medications that alter sleep, you may not be eligible to participate.

What prior data suggests that this cognitive training is safe for autistic adults with insomnia?

Research has shown that COGMUSE, a new program designed to improve thinking skills, is being tested for safety in autistic adults who have trouble sleeping. Although specific safety information about COGMUSE is limited, these types of programs are generally easy to handle. They typically involve tasks or games to boost mental abilities and lack the side effects often associated with medications.

The study aims to determine if the program can be used effectively at home and will monitor for any possible side effects during the 6-week training period. Participants will have regular check-ins to report how they are feeling, which helps ensure the program's safety for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about COGMUSE because it offers a novel approach to managing autism and insomnia through cognitive training. Unlike traditional treatments that often rely on medications or behavioral therapy, COGMUSE utilizes a computerized cognitive training program. This method is designed to enhance cognitive functions by engaging users in targeted mental exercises, which can be conveniently performed at home. The potential for non-pharmacological intervention with minimal side effects makes COGMUSE a promising alternative for individuals seeking innovative treatment options.

What evidence suggests that COGMUSE is effective for autism and insomnia?

Research has shown that cognitive behavioral treatments can improve sleep and reduce challenging behaviors in autistic children with insomnia. In individuals with insomnia, cognitive training has improved sleep quality, mood, and mental performance. These findings suggest that COGMUSE, the cognitive training program under study in this trial, may aid autistic adults with insomnia by enhancing sleep and mental functions. Although direct data on COGMUSE is limited, the success of similar programs offers promising signs for its potential effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Ashley F Curtis, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Autism Spectrum Disorder (ASD) and insomnia. Participants must have a verbal IQ of at least 70, be able to read English, and not use sleep medications or have stable medication use for six weeks. They should also have documented ASD diagnosis confirmed by clinical tools like ADOS or ADI-R.

Inclusion Criteria

I have been diagnosed with Autism Spectrum Disorder (ASD).

My verbal IQ is 70 or above, ensuring I can participate in treatment discussions.

I can read and understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home, totaling 18 hours. Weekly check-ins are conducted by study staff over Teams.

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the completion of various assessments and questionnaires.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COGMUSE

Trial Overview The study tests COGMUSE-AUT, a cognitive training program designed for autistic adults with insomnia. It involves playing the game at home for an hour per day, three times a week over six weeks while wearing an actigraph device to monitor sleep patterns.

How Is the Trial Designed?

Group I: COGMUSE-AUT Experimental Treatment 1 Intervention

Participants will complete the computerized cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Published Research Related to This Trial

The CBT-i Coach mobile app significantly improved subjective sleep outcomes in veterans, with participants reporting reduced insomnia and better sleep quality after a 6-week intervention, despite a decrease in objective sleep time.

The study highlights the importance of using both subjective and objective sleep measures, as the objective data revealed a decrease in sleep time and no changes in REM sleep or sleep efficiency, suggesting potential undiagnosed sleep apnea in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Reilly, ED., Robinson, SA., Petrakis, BA., et al.[2020]

A hybrid trial is testing the effectiveness of Brief Behavioral Treatment for Insomnia (BBTI) compared to the standard Cognitive Behavioral Therapy for Insomnia (CBTI) to improve access to treatment for Veterans suffering from chronic insomnia.

The study also includes a qualitative assessment to identify barriers and facilitators for implementing insomnia treatments in primary care settings, aiming to enhance access to effective care for Veterans who may face challenges in reaching specialized services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid type I trial to increase Veterans' access to insomnia care: study protocol for a randomized controlled trial. Bramoweth, AD., Germain, A., Youk, AO., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBT-i) is the most effective nonpharmacological treatment for chronic insomnia, providing results comparable to sleep medications without side effects and promoting long-term improvements in sleep quality.

Despite its effectiveness and safety, CBT-i is underutilized due to a shortage of trained practitioners and a greater public awareness of sleep medications, highlighting the need for healthcare providers to educate patients about CBT-i as a first-line treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Therapy for Insomnia: An Effective and Underutilized Treatment for Insomnia. Rossman, J.[2020]

Benzodiazepines and atypical GABA agonists can cause cognitive impairment in individuals with traumatic brain injury (TBI), particularly when their plasma levels are high, raising concerns about their safety in this population.

Alternatives like trazodone and melatonin agonists may be safer options for treating insomnia in TBI patients, but more research is needed to fully understand their effects on neuroplasticity and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep medications on cognitive recovery from traumatic brain injury. Larson, EB., Zollman, FS.[2013]

A pilot study involving 17 children with autism and insomnia showed that an 8-session cognitive behavioral treatment for childhood insomnia (CBT-CI) significantly improved both child and parent sleep, as well as reduced challenging behaviors like irritability and hyperactivity.

Parents reported that CBT-CI was helpful and suitable for their children, indicating that this treatment is feasible and promising for addressing insomnia in school-aged children with autism, warranting further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. McCrae, CS., Chan, WS., Curtis, AF., et al.[2020]

In a study of 631 adults with autism spectrum disorder (ASD), insomnia severity was found to be positively associated with sensory hyper-reactivity and impaired social skills, suggesting these factors may contribute to sleep difficulties.

The results indicate that sensory avoidance and social interaction challenges could disrupt the circadian sleep-wake rhythm in individuals with ASD, highlighting the need for further research into the biological mechanisms behind these associations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia Severity in Adults with Autism Spectrum Disorder is Associated with sensory Hyper-Reactivity and Social Skill Impairment. Hohn, VD., de Veld, DMJ., Mataw, KJS., et al.[2020]

Insomnia significantly impacts public health, affecting quality of life and leading to various health issues, making effective treatment essential.

The review highlights that while there are effective non-medication treatments like cognitive behavioral therapy and various pharmacologic options, many commonly used therapies lack rigorous clinical trial evidence, indicating a need for more research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The assessment and management of insomnia: an update. Krystal, AD., Prather, AA., Ashbrook, LH.[2020]

In a study of 270 children with autism spectrum disorder (ASD), one-third were found to have insomnia, highlighting its prevalence in this population.

Insomnia in these children was associated with reduced adaptive behaviors and increased parental stress, suggesting that addressing sleep issues could help improve overall well-being for both children and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia in Children with Autism Spectrum Disorder: A Cross-Sectional Study on Clinical Correlates and Parental Stress. Bianca, B., Silvia, G., Elisa, F., et al.[2023]

This study will be the first to evaluate cognitive behavioral treatment for childhood insomnia (CBT-CI) specifically adapted for children with autism spectrum disorder (ASD) and insomnia, involving 180 participants aged 6-12 years.

The trial aims to assess the effectiveness of CBT-CI in reducing insomnia and its negative impacts on children with ASD, with outcomes measured at multiple time points, including sleep quality, daytime functioning, and parental stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. McCrae, CS., Mazurek, MO., Curtis, AF., et al.[2021]

A manualized multi-component behavioral sleep intervention was effective in reducing sleep onset latency for all three children with autism spectrum disorder (ASD) and primary insomnia, as measured by both subjective and objective assessments.

Improvements in sleep onset latency were maintained 12 weeks after the intervention, suggesting the long-term efficacy of the treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case study: A case-series evaluation of a behavioral sleep intervention for three children with autism and primary insomnia. Moon, EC., Corkum, P., Smith, IM.[2015]

In a study of 427 hospitalized children with autism spectrum disorder, 60% were reported to have insomnia, with the most common subtype being multiple insomnia symptoms (44.7%).

Children experiencing difficulty staying asleep or multiple insomnia symptoms had poorer adaptive behaviors and longer hospital stays, indicating a strong link between these insomnia types and impaired behavioral functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia subtypes and clinical impairment in hospitalized children with autism spectrum disorder. Taylor, BJ., Reynolds, CF., Siegel, M.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06291298

Novel Adaptive Cognitive Training in Autistic Adults with ... The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- ...

2. withpower.com withpower.com/trial/cognitive-training-for-autism-and-insomnia-faa90

Cognitive Training for Autism and Insomnia Research shows that cognitive behavioral treatment for childhood insomnia (CBT-CI) can improve sleep and reduce challenging behaviors in children with autism, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002878

Protocol of a randomized controlled trial into guided ... This trial can reveal whether autistic adults with insomnia benefit from a guided e-health intervention.

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

Assessing the Effectiveness of a Computerized Home- ... Conclusions: In patients with insomnia, cognitive stimulation demonstrated improvements in sleep quality, mood, and cognitive performance over ...

5. trialx.com trialx.com/clinical-trials/listings/317941/novel-adaptive-cognitive-training-in-autistic-adults-with-co-occurring-insomnia/

Novel Adaptive Cognitive Training in Autistic Adults with ... The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04545606

Targeting Insomnia in School Aged Children With Autism ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. health.usf.edu health.usf.edu/nursing/research/researchers/ashley-curtis

Ashley Curtis - USF Health - University of South Florida Novel Adaptive Cognitive Training in Autistic Adults with Co-Occurring Insomnia (COGMUSE-AUT) ... This study aims to address challenges faced by autistic adults ...