Follow-up of NIV At Home in Patients with Duchenne Muscular Dystrophy

NCT ID: NCT06773988

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-06

Study Completion Date

2027-12-31

Brief Summary

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The aim of this study is to verify whether full video home polysomnography (sleep study) with nocturnal transcutaneous CO2 monitoring is feasible in the follow-up of non-invasive ventilation (NIV) in patients with Duchenne muscular dystrophy. The researchers would like to investigate whether they could perform sufficient measurements in the home situation and see if correct decision for further treatment could be made. Furthermore, the researchers will make an analysis on the minimal requirements of measurements to make a correct decision for the treatment of these patients.

Detailed Description

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Conditions

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Duchenne Muscular Dystrophy (DMD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with Duchenne using NIV in follow-up at the Leuven University Center for Sleep/wake

Patients with Duchenne Muscular Dystrophy (DMD) on non-invasive ventilation (NIV) who need a yearly follow up by polysomnopgraphy

Monitoring of NIV at home

Intervention Type DIAGNOSTIC_TEST

Monitoring of NIV at home

Interventions

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Monitoring of NIV at home

Monitoring of NIV at home

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with DMD \> 18 years using NIV
* Signing the written informed consent

Exclusion Criteria

* /
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitaire Ziekenhuizen KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dries Testelmans, MD PHD

Role: CONTACT

+3216342522

Bart Vrijsen, PT PHD

Role: CONTACT

+3216342522

Facility Contacts

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Bart Vrijsen, PhD

Role: primary

32 16 342522

References

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Bruyneel M, Ninane V. Unattended home-based polysomnography for sleep disordered breathing: current concepts and perspectives. Sleep Med Rev. 2014 Aug;18(4):341-7. doi: 10.1016/j.smrv.2013.12.002. Epub 2013 Dec 12.

Reference Type BACKGROUND
PMID: 24388970 (View on PubMed)

Toussaint M, Chatwin M, Soudon P. Mechanical ventilation in Duchenne patients with chronic respiratory insufficiency: clinical implications of 20 years published experience. Chron Respir Dis. 2007;4(3):167-77. doi: 10.1177/1479972307080697.

Reference Type BACKGROUND
PMID: 17711917 (View on PubMed)

Bourke SC. Respiratory involvement in neuromuscular disease. Clin Med (Lond). 2014 Feb;14(1):72-5. doi: 10.7861/clinmedicine.14-1-72. No abstract available.

Reference Type BACKGROUND
PMID: 24532751 (View on PubMed)

Other Identifiers

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S68844

Identifier Type: -

Identifier Source: org_study_id

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