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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 belowSelect...
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 weeks3 visits
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.
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.
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
1,789 Previous Clinical Trials
16,359,523 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a parent/caregiver of a child aged 6-17 with Duchenne muscular dystrophy living at home.I have a smartphone or computer with internet for weekly sessions and data uploads.My child with DMD is being treated for a sleep disorder.Your child with DMD has thinking or behavior problems that would make it hard for them to take part in the study or stick to the treatment plan.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Intervention
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