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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ 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.

Locations
United States
Florida
University of South Florida
RECRUITING
Tampa
Contact Information
Primary
Ashley Curtis, PhD
ashleycurtis@usf.edu
813-396-0254
Backup
Susan S Rodriguez, BA
srodriguez26@usf.edu
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-04-01
Participants
Target number of participants: 15
Treatments
Experimental: COGMUSE-AUT
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.
Related Therapeutic Areas
Sponsors
Leads: University of South Florida

This content was sourced from clinicaltrials.gov