University of South Florida
Tampa, Florida, 33620, United States
NCT Number: NCT06291298
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tampa, Florida, 33620, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
Time frame: Up to 10 weeks
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.
Time frame: Up to 10 weeks
GENEActiv (Activiinsights), a watch-like device that monitors light and gross motor activity, will be worn 24 hours/7 days for 2 weeks at each assessment point.
Time frame: Up to 10 weeks
Online diaries completed each morning (~5 mins) during 2-week assessment periods and 6 weeks training. Variables: sleep onset latency (time from lights-out until sleep onset), wake time after sleep onset, sleep efficiency (% time spent sleeping while in bed).
Time frame: Up to 10 weeks
5-item survey completed by adult with autism and parent/guardian if needed. Brief measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
Time frame: Up to 10 weeks
Modified Sleep Habits Questionnaire, based on child version and modified for adults. This questionnaire gauges sleep habits and possible difficulties with sleep.
Time frame: Up to 10 weeks
-Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal. This questionnaire will be completed by autistic adult with assistance from parent/guardian as needed.
Time frame: Up to 10 weeks
This measure assesses quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards and concerns.
Time frame: Up to 10 weeks
State-Trait Anxiety Inventory: Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
Time frame: Up to 10 weeks
Time frame: Up to 10 weeks
Adaptive functioning --This assessment measures behaviors suitable for adults displayed in several domains such as communication, community use, functional academics, home living, health and safety, leisure, self-care, self-direction, social, and work. The assessment will be filled by the adult with autism with the help of the caregiver if necessary. Answers are provided in a likert scale with 0=is not able to do this behavior to 3= always (or almost always).
Time frame: Up to 10 weeks
Sessions played -- The graduate research assistant will check adherence through an online portal storing COGMUSESM data during weekly Teams check-ins with participant. Participants will also provide qualitative feedback on the game sessions played.
Weekly game -- Maximum test scores recorded.
Game Engagement Questionnaire - Completed at the end of intervention; Participants rate from 0 (none) to 4 (extremely) the degree to which they agree with 33 aspects of game experiences. Total score measures game engagement.
University of South Florida
Other
COGMUSE-AUT: Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia
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