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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

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

DMD Trial 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.Check my eligibility

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.See study design

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.

DMD Trial 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.

DMD Trial 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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parent Mastery Questionnaire

Secondary outcome measures

Child intradaily variability from Actigraphy

Child relative amplitude from Actigraph

DMD 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,836 Total Patients Enrolled

Angela Caldwell, PhDPrincipal InvestigatorUniversity of Pittsburgh

2 Previous Clinical Trials

78 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to adults beyond 20 years of age?

"This experiment seeks participants aged between 6 and 18 years old."

Answered by AI

Is there currently an open call for participants in this clinical trial?

"According to clinicaltrials.gov, this medical study is actively seeking participants; it was initially posted on February 17th 2021 and the details were last updated on July 1st 2022."

Answered by AI

What qualifications must an individual meet in order to be a participant of this experiment?

"This trial is accepting up to 100 patients between 6 and 18 years old who suffer from Duchenne muscular dystrophy."

Answered by AI

What is the participant count for this research endeavor?

"Affirmative. Clinicaltrials.gov attests that the trial, which was first announced on February 17th 2021, is currently seeking participants. The investigators anticipate recruiting a hundred individuals from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep Intervention in Young Boys With Duchenne Muscular Dystrophy

Angela Caldwell 2021. "Sleep Intervention in Young Boys With Duchenne Muscular Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04529707.

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