Sleep Intervention in Young Boys With Duchenne Muscular Dystrophy (DMD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04529707|
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Duchenne Muscular Dystrophy||Behavioral: Transdiagnostic Behavioral Sleep Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The overall objective of this project is to conduct an early phase single-group repeated measures design project examining the implementation and within-subjects effects of a 10-week parent-mediated TranS-CY program to improve sleep health in young boys with DMD.|
|Masking:||None (Open Label)|
|Official Title:||Sleep Health Dysfunction and the Use of a Transdiagnostic Sleep Intervention in Duchenne Muscular Dystrophy|
|Estimated Study Start Date :||February 22, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Sleep Intervention
All participants will engage in a 10-week, parent mediated sleep intervention with weekly education sessions.
Behavioral: Transdiagnostic Behavioral Sleep Intervention
The Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-CY) uses a comprehensive sleep health framework along with robust evidence for promoting healthy sleep patterns in youth. The TranS-CY incorporates best practices from numerous efficacious behavioral sleep interventions including 1) cognitive behavioral therapy, 2) interpersonal and social rhythm therapy, and 3) behavioral treatment of circadian rhythm sleep-wake disorders. The "traditional" TranS-CY is clinician-led and provides a robust sleep treatment framework for youth with a wide range of disorders and sleep health concerns. For this study, investigators are using the basic framework of the TranS-CY, but clinicians will train parents to incorporate the intervention into the home for their young child with DMD. Trained clinicians will work with parents to ensure the basic components of the TranS-CY are incorporated into the home-based intervention.
- Parent Mastery Questionnaire [ Time Frame: A 10-item questionnaire focused on intervention modules will be delivered every 2-3 weeks during the 10 week intervention. Parents will be required to answer questions that address their knowledge of the information provided in each module. ]100% of parents who are retained throughout the study will attain ≥80% knowledge accuracy at each knowledge check time point and will accurately answer 8 of the 10 questions provided.
- Child intradaily variability from Actigraphy [ Time Frame: 2 weeks pre-intervention and 2 weeks post-intervention ]Vector magnitude scores from Actigraphy for each 2-week data collection period (pre and post intervention) are analyzed through nParAct software. Analyses provide us with our secondary outcome of intradaily variability. Intradaily variability is the frequency and extent of transitions between periods of rest and activity on an hourly basis over 24 hours. Relative amplitude is how active a child is during a 24 hour period.
- Child relative amplitude from Actigraph [ Time Frame: 2 weeks pre-intervention and 2 weeks post-intervention. ]Vector magnitude scores from Actigraphy for each 2-week data collection period (pre and post intervention) are analyzed through nParAct software. Analyses provide us with our secondary outcome of relative amplitude. Relative amplitude is how active a child is during a 24 hour period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529707
|Contact: Roxanna M Bendixen, PhDemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15219|
|Contact: Roxanna M Bendixen, Ph.D. 412-383-6603 firstname.lastname@example.org|
|Principal Investigator:||Roxanna M Bendixen, PhD||University of Pittsburgh|