RecruitingNot ApplicableNCT06291298

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

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


Sponsor

University of South Florida

Enrollment

15 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 18+ years of age
  • Diagnosed with ASD (see 2a).
  • Verbal IQ >= 70 (Measured via the Weschler Abbreviated Scale of Intelligence 2nd Edition28); to ensure verbal skills sufficient to participate in treatment
  • Able to undergo actigraphy assessment
  • Can read and understand English
  • Diagnosed with insomnia (See 3a).
  • No prescribed or OTC sleep medications for 1+ month, or stabilized on medications for 6+ weeks.
  • a) 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 \[ADI-R\]).
  • a) 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 Criteria7

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

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Interventions

BEHAVIORALCOGMUSE-AUT

The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.


Locations(1)

University of South Florida

Tampa, Florida, United States

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NCT06291298


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