Autism Spectrum DisorderNCT06291298
Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia
A study testing COGMUSE-AUT in people with Autism Spectrum Disorder and Insomnia, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Insomnia
- What is being tested?
- COGMUSE-AUT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- unable to provide informed consent
- 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)],
- comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment)
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
- severe untreated psychiatric comorbidity
- psychotropic or other medications (e.g., beta-blockers) that alter sleep
- participation in non-pharmacological treatment (including CBT) for pain, sleep or mood outside current trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COGMUSE-AUT: Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia
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.
- Conditions
- Autism Spectrum Disorder, Insomnia
- Being tested
- COGMUSE-AUT
- Medical subject headings
- Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGMUSE-AUTBehavioural
The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
| Study group | Role | What they receive |
|---|---|---|
| COGMUSE-AUT | Experimental | 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. Receives: Behavioral: COGMUSE-AUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Cognition-National Institute of Health Toolbox
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.
Measured: Up to 10 weeks
Secondary outcomes (10)
Objective Slee-Daily Actigraphy
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.
Measured: Up to 10 weeks
Subjective Sleep- Electronic Daily Sleep Diaries
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).
Measured: Up to 10 weeks
Insomnia Severity Index
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.
Measured: Up to 10 weeks
Sleep Habits Questionnaire
Modified Sleep Habits Questionnaire, based on child version and modified for adults. This questionnaire gauges sleep habits and possible difficulties with sleep.
Measured: Up to 10 weeks
Pre-Sleep Arousal
-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.
Measured: Up to 10 weeks
WHO Quality of Life-BREF
This measure assesses quality of life (QOL) within the context of an individual's culture, value systems, personal goals, standards and concerns.
Measured: Up to 10 weeks
Mood
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.
Measured: Up to 10 weeks
Depression
- Beck Depression Inventory (II): 21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.
Measured: Up to 10 weeks
Adaptive Behavior Assessment System (ABAS-III)
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).
Measured: Up to 10 weeks
Game-related experience (completed during intervention)
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.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Mar 2024
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Curtis, University of South Florida
- Investigators
- Ashley F Curtis, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291298
- Sponsor's protocol ID
- STUDY006542
- Status last verified
- May 2026
- First submitted
- 26 Feb 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COGMUSE-AUT: Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia
- ClinicalTrials.gov ID
- NCT06291298
- Acronym / sponsor ID
- STUDY006542
- Conditions
- Autism Spectrum Disorder, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes.
| Arm | Type | Receives |
|---|---|---|
| COGMUSE-AUT | Experimental | Behavioral: COGMUSE-AUTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- unable to provide informed consent
- 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)],
- comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment)
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
- severe untreated psychiatric comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COGMUSE-AUTThe computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills. | Behavioural | COGMUSE-AUT |
Primary outcome
Objective Cognition-National Institute of Health Toolbox
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.
10 secondary outcomes
Objective Slee-Daily Actigraphy
Time frame: Up to 10 weeks
Subjective Sleep- Electronic Daily Sleep Diaries
Time frame: Up to 10 weeks
Insomnia Severity Index
Time frame: Up to 10 weeks
Sleep Habits Questionnaire
Time frame: Up to 10 weeks
Pre-Sleep Arousal
Time frame: Up to 10 weeks
WHO Quality of Life-BREF
Time frame: Up to 10 weeks
Mood
Time frame: Up to 10 weeks
Depression
Time frame: Up to 10 weeks
Adaptive Behavior Assessment System (ABAS-III)
Time frame: Up to 10 weeks
Game-related experience (completed during intervention)
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley F Curtis, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COGMUSE-AUT in people with Autism Spectrum Disorder and Insomnia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Cognition-National Institute of Health Toolbox (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.