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Sleep Intervention for Duchenne Muscular Dystrophy (DMD Trial)

N/A
Recruiting
Led By Angela Caldwell, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Access to a smart-phone or computer and internet for the weekly web-based sessions, as well as uploading of the Actigraph data
Be younger than 65 years old
Must not have
Their child/youth with DMD is currently receiving an intervention for a sleep related disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a sleep and circadian intervention can be consistently taught and implemented by parents into the home setting, with the goal of improving youth sleep.

Who is the study for?
This trial is for English-speaking parents or caregivers of boys aged 6-17 with Duchenne Muscular Dystrophy (DMD) who live at home and have access to a smartphone or computer with internet. It's not suitable for those whose children have cognitive/behavioral issues that would limit participation, or are currently receiving sleep disorder treatments.
What is being tested?
The study tests the Transdiagnostic Sleep and Circadian Intervention (TranS-CY), delivered through weekly remote parent training sessions via video web conferencing. The goal is to see if parents can learn and apply strategies like motivational interviewing, goal setting, problem solving, and sleep routine scheduling at home.
What are the potential side effects?
Since this intervention involves behavioral techniques rather than medication, traditional side effects are not expected. However, participants may experience changes in daily routines which could temporarily affect the child’s behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a smartphone or computer with internet for weekly sessions and data uploads.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child with DMD is being treated for a sleep disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Parent Mastery Questionnaire
Secondary study objectives
Child intradaily variability from Actigraphy
Child relative amplitude from Actigraph

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: Sleep InterventionExperimental Treatment1 Intervention
All participants will engage in a 10-week, parent mediated sleep intervention with weekly education sessions.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,886 Total Patients Enrolled
Angela Caldwell, PhDPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
93 Total Patients Enrolled
Roxanna M Bendixen, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Transdiagnostic Behavioral Sleep Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04529707 — N/A
Duchenne Muscular Dystrophy Clinical Trial 2023: Transdiagnostic Behavioral Sleep Intervention Highlights & Side Effects. Trial Name: NCT04529707 — N/A
Transdiagnostic Behavioral Sleep Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04529707 — N/A
Duchenne Muscular Dystrophy Research Study Groups: Sleep Intervention
~21 spots leftby Dec 2025