Cognitive training for autistic adults with insomnia

COGMUSE-AUT: Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia

This study is testing a new cognitive training program to see if it can help autistic adults with insomnia sleep better and think more clearly.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of South Florida (other)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06291298 on ClinicalTrials.gov

What this trial studies

This study tests the usability and feasibility of a novel cognitive training program called COGMUSE for autistic adults who also experience insomnia. Participants will engage in the training for 60 minutes, three times a week for six weeks, while receiving weekly check-ins from study staff via Teams. They will also maintain daily electronic sleep diaries and wear a device to monitor their sleep patterns and activity levels. The goal is to assess how well this intervention can help improve sleep and cognitive function in this population.

Who should consider this trial

Good fit: Ideal candidates are autistic adults aged 18 and older who have a diagnosis of insomnia and meet specific cognitive and health criteria.

Not a fit: Patients who are currently taking sleep medications or have not been off such medications for at least one month may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could improve sleep quality and cognitive functioning in autistic adults with insomnia.

How similar studies have performed: While this approach is innovative, similar cognitive training interventions have shown promise in other populations, suggesting potential for success in this context.

Eligibility criteria

Inclusion Criteria:

1. 18+ years of age
2. Diagnosed with ASD (see 2a).
3. Verbal IQ \>= 70 (Measured via the Weschler Abbreviated Scale of Intelligence 2nd Edition28); to ensure verbal skills sufficient to participate in treatment
4. Able to undergo actigraphy assessment
5. Can read and understand English
6. Diagnosed with insomnia (See 3a).
7. No prescribed or OTC sleep medications for 1+ month, or stabilized on medications for 6+ weeks.

2a) ASDb: a) previous DSM diagnosis of ASD (self-reported by ASD adult and guardian; confirmed by clinical documentation provided to project coordinator), 2) evaluation using gold-standard diagnostic tools (i.e., Autism Diagnostic Observation Schedule (ADOS) and/or Autism Diagnostic Interview -Revised \[ADI-R\]).

3a) Insomnia: a) insomnia complaints for 6+ months that b) occur despite adequate opportunity and circumstances for sleep, c) consist of 1 or more of the following: difficulty falling asleep, staying asleep, or waking up too early, d) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, f) baseline diaries and actigraphy indicate \>30 minutes of sleep onset latency or wake after sleep onset on 6 or more nights.

Exclusion Criteria:

1. unable to provide informed consent
2. diagnosis of sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, AHI \>15), Periodic Limb Movement Disorder (myoclonus arousals per hour \>15)\],
3. comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment)
4. other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
5. severe untreated psychiatric comorbidity
6. psychotropic or other medications (e.g., beta-blockers) that alter sleep
7. participation in non-pharmacological treatment (including CBT) for pain, sleep or mood outside current trial.

Where this trial is running

Tampa, Florida

• University of South Florida — Tampa, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Ashley F Curtis, PhD — University of South Florida
• Study coordinator: Ashley Curtis, PhD

Conditions: Autism Spectrum Disorder, Insomnia