Novel Adaptive Cognitive Training in Autistic Adults with Co-occurring Insomnia
NCT ID: NCT06291298
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-03-01
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
COGMUSE-AUT
The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
Interventions
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COGMUSE-AUT
The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Ashley Curtis
Assistant Professor
Principal Investigators
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Ashley F Curtis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Susan Rodriguez S Project Coordinator
Role: primary
Other Identifiers
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STUDY006542
Identifier Type: -
Identifier Source: org_study_id