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

NCT06291298 | Completed

• 1 other identifier: STUDY006542
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder; Insomnia

Outcome Measures

Primary Outcomes (1)

• Objective Cognition-National Institute of Health Toolbox

  A computerized cognitive test battery measuring performance across several domains: executive function (Flanker inhibitory control task), Dimensional Card Sort Test (measures cognitive flexibility, accuracy score), working memory (List Sorting Task), verbal (episodic) memory (Auditory Verbal Learning Task) will be administered.

  Up to 10 weeks

Secondary Outcomes (10)

• Objective Slee-Daily Actigraphy

  Up to 10 weeks

• Subjective Sleep- Electronic Daily Sleep Diaries

  Up to 10 weeks

• Insomnia Severity Index

  Up to 10 weeks

• Sleep Habits Questionnaire

  Up to 10 weeks

• Pre-Sleep Arousal

  Up to 10 weeks

Study Arms (1)

COGMUSE-AUT

EXPERIMENTAL

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.

Behavioral: COGMUSE-AUT

Interventions

COGMUSE-AUT BEHAVIORAL

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

COGMUSE-AUT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ashley F Curtis, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: March 1, 2024
• Primary Completion: May 11, 2026
• Study Completion: May 11, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)