RECRUITING

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

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Conditions

Autism Spectrum DisorderInsomnia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06291298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18+ years of age
  2. 2. Diagnosed with ASD (see 2a).
  3. 3. Verbal IQ \>= 70 (Measured via the Weschler Abbreviated Scale of Intelligence 2nd Edition28); to ensure verbal skills sufficient to participate in treatment
  4. 4. Able to undergo actigraphy assessment
  5. 5. Can read and understand English
  6. 6. Diagnosed with insomnia (See 3a).
  7. 7. No prescribed or OTC sleep medications for 1+ month, or stabilized on medications for 6+ weeks.
  1. 1. unable to provide informed consent
  2. 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. 3. comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment)
  4. 4. other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
  5. 5. severe untreated psychiatric comorbidity
  6. 6. psychotropic or other medications (e.g., beta-blockers) that alter sleep
  7. 7. participation in non-pharmacological treatment (including CBT) for pain, sleep or mood outside current trial.

Contacts and Locations

Study Contact

Ashley Curtis, PhD
CONTACT
813-396-0254
ashleycurtis@usf.edu
Susan S Rodriguez, BA
CONTACT
srodriguez26@usf.edu

Principal Investigator

Ashley F Curtis, PhD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

University of South Florida
Tampa, Florida, 33620
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Ashley F Curtis, PhD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Insomnia