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Recruiting NCT06773988

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

— Observational Duchenne Muscular Dystrophy (DMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monitoring of NIV at home.
Who it may be relevant to
Registry conditions: Duchenne Muscular Dystrophy (DMD). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Diagnostic test Monitoring of NIV at home
    Monitoring of NIV at home

Primary outcome measures

  • The feasibility of full video home polysomnography (PSG) and follow-up at home in patients with DMD on NIV, identical to the sophisticated PSG in-hospital [Time frame: Yearly home polysomnopraphy and Transcutaneous CO2 measurement, for a period of 3 years]
Secondary outcome measures (7)
  • Analysis of the minimal equipment to assure a correct follow-up of NIV at home (full video PSG vs PtcCO2) measurement combined with ventilator software data vs ventilator software data vs PtcCO2 measurement) [Time frame: 3 years]
  • Cost-benefit analysis of follow-up of NIV at home as a preparation to create a file for the Belgian health insurance (registration of time and material) [Time frame: Cost-benifit analysis will be carried out at study completion, after 3 years.]
  • Amount of technical failures, i.e. PSG signals, PtcCO2 measurement, O2 saturation measurement and video monitoring. [Time frame: Performed immediately after each PSG or PtcCO2 measurement, during a period of 3 years.]
  • Patient Reported Outcomes: Experience between in-hospital PSG vs PSG at home [Time frame: The PROM will be completed by the patient at each yearly PSG, during the 3 years of the ongoing study]
  • Sleep quality questionnaire: The Pittsburgh Sleep Quality Index (PSQI) [Time frame: The PSQI will be completed by the patient at each yearly PSG and at each yearly PtcCO2 measurment, during 3 years.]
  • Home-NIV PROM: S3-NIV [Time frame: The S3-NIV questionnaire will be completed by the patient at each yearly PSG and at each yearly PTCO2 measurement, during 3 years.]
  • Daytime sleepiness questionnaire: Epworth Sleepiness Scale (ESS) [Time frame: The ESS questionnaire will be completed by the patient at each yearly PSG and each yearly PtcCO2 measurement, during 3 years.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • /

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Universitaire Ziekenhuizen KU Leuven — Leuven

Publications

  • 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. PMID 24388970
  • 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. PMID 17711917
  • 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. PMID 24532751

Identifiers

NCT: NCT06773988 · S68844

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗