Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Roxanna Marie Bendixen, University of Pittsburgh

Brief Summary:
This project will systematically plan and evaluate the implementation of the Transdiagnostic Sleep and Circadian Intervention for youth (TranS-CY). As an early stage study, investigators will focus on recruitment strategies to reach the target population and collection of preliminary data on primary and secondary effects of the TranS-CY. Weekly remote (video web conferencing) parent training sessions will allow investigators to explore adoption through parent adherence and examine whether the essential elements of the TranS-CY intervention (e.g., motivational interviewing, goal setting, problem solving, sleep routine scheduling, monitoring) can be consistently taught by clinicians and implemented by parents into the home setting.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Behavioral: Transdiagnostic Behavioral Sleep Intervention Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
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)
Primary Purpose: Treatment
Official Title: Sleep Health Dysfunction and the Use of a Transdiagnostic Sleep Intervention in Duchenne Muscular Dystrophy
Actual Study Start Date : February 17, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents/caregivers of youth between ages 6 and 17 with a primary diagnosis of Duchenne muscular dystrophy (DMD) who lives at home .
  • Access to a smart-phone or computer and internet for the weekly web-based sessions, as well as uploading of the Actigraph data;
  • English speaking.

Exclusion Criteria:

  • Unable to speak or read English
  • Their child with DMD has cognitive or behavioral concerns that would limit participation and follow-through of intervention;
  • Their child/youth with DMD is currently receiving an intervention for a sleep related disorder

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Roxanna M Bendixen, PhD 412-383-6603 bendixen@pitt.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Roxanna M Bendixen, Ph.D.    412-383-6603    bendixen@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Roxanna M Bendixen, PhD University of Pittsburgh
Layout table for additonal information
Responsible Party: Roxanna Marie Bendixen, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04529707    
Other Study ID Numbers: STUDY20030019
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This is a preliminary study focused on determining if the TranS-CY can be modified and implemented into the home by parents of young boys with DMD. The primary and secondary outcomes are focused on collecting data regarding parent knowledge of the intervention components and change in intradaily variability and relative amplitude (through Actigraphy) of the child with DMD pre and post intervention.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: IPD and additional supporting information will be made available approximately 3 months after summary data are published or otherwise disseminated.
Access Criteria: IPD will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions. The full study protocol and informed consent forms will be shared. Only aggregate and de-identified data collected throughout the clinical trial will be shared.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roxanna Marie Bendixen, University of Pittsburgh:
Duchenne Muscular Dystrophy
Sleep
Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked