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Behavioral Intervention

Cognitive Training for Autism and Insomnia

N/A

Recruiting

Led By Ashley F Curtis, PhD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18+ years of age

Diagnosed with insomnia (See 3a).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cognitive training program called COGMUSE for autistic adults who also have trouble sleeping. Participants will do the training for 60 minutes, 3 times a week for 6

Who is the study for?

This trial is for adults over 18 with Autism Spectrum Disorder (ASD) and insomnia. Participants must have a verbal IQ of at least 70, be able to read English, and not use sleep medications or have stable medication use for six weeks. They should also have documented ASD diagnosis confirmed by clinical tools like ADOS or ADI-R.

What is being tested?

The study tests COGMUSE-AUT, a cognitive training program designed for autistic adults with insomnia. It involves playing the game at home for an hour per day, three times a week over six weeks while wearing an actigraph device to monitor sleep patterns.

What are the potential side effects?

Since this is a non-pharmaceutical intervention focusing on cognitive training exercises, significant physical side effects are not anticipated. However, participants may experience changes in their sleeping patterns or potential frustration if they find the tasks challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with insomnia.

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I haven't taken sleep meds for over a month or my sleep meds have been stable for 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Cognition-National Institute of Health Toolbox

Secondary study objectives

Adaptive Behavior Assessment System (ABAS-III)

Depression

Game-related experience (completed during intervention)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: COGMUSE-AUTExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met