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Longitudinal Study on Diaframmatic Ultrasound in FSHD Patients

RecruitingNAAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT06078852 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this prospective, longitudinal, single-center study is to describe respiratory function in patients affected by FSHD at baseline and after one year using both diaphragmatic ultrasound and pulmonary function test. The primary questions this study aims to answer are: 1. How does respiratory function assessed by diaphragmatic ultrasound and pulmonary function tests change over 12 months in FSHD patients? 2. How accurate is diaphragmatic ultrasound in detecting respiratory abnormalities in these patients compared to pulmonary function tests? 3. What is the relationship between ultrasound and functional indices, and how do these indices correlate with demographic, clinical, and genetic data? To achieve this, we will enroll a cohort of 34 patients affected by FSHD, and each of them will undergo a comprehensive neurological examination, body plethysmography, measurement of maximal

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of FSHD, genetically confirmed. * Adult patients (18 years or older) * Signature from the patient on the written informed consent document Exclusion Criteria: \- Medical history of neck and mediastinal trauma and/or surgery and/or radiation therapy (e.g. total thyroidectomy, mastectomy) with evidence of phrenic nerve injury.
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What it tests

  • Diaphragmatic ultrasound
  • Pulmonary function test
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Where

1 site
Fondazione Policlinico Gemelli IRCCS
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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