Clinical trial NCT06291298: Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia
Official title: COGMUSE-AUT: Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Insomnia
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Objective Cognition-National Institute of Health Toolbox
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Objective Slee-Daily Actigraphy
timeFrame: Up to 10 weeks
measure: Subjective Sleep- Electronic Daily Sleep Diaries
timeFrame: Up to 10 weeks
measure: Insomnia Severity Index
timeFrame: Up to 10 weeks
measure: Sleep Habits Questionnaire
timeFrame: Up to 10 weeks
measure: Pre-Sleep Arousal
timeFrame: Up to 10 weeks
measure: WHO Quality of Life-BREF
timeFrame: Up to 10 weeks
measure: Mood
timeFrame: Up to 10 weeks
measure: Depression
timeFrame: Up to 10 weeks
measure: Adaptive Behavior Assessment System (ABAS-III)
timeFrame: Up to 10 weeks
measure: Game-related experience (completed during intervention)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Ashley F Curtis, PhD
role: PRINCIPAL_INVESTIGATOR
References: