Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT04052958
Eligibility Criteria:
Inclusion Criteria:
* the patient is willing and able to provide a signed informed consent form
* the patient is ≥ 18 years old
* the diagnosis of type 1 myotonic dystrophy has been confirmed by molecular genetics
* the patient is able and willing to perform pulmonary function tests (PFT) and blood sampling for capillary blood gas analysis (pO2, pCO2) throughout the study, to keep a diary and to complete questionnaires
Exclusion Criteria:
* the patient requires invasive ventilation (non-invasive ventilation is allowed).
* the patient uses non-invasive ventilation more than 16h/day.
* the patient participates in another clinical study that involves therapy.
* the patient cannot perform pulmonary function tests (PFT).
* the patient is diagnosed with central sleep apnea in polysomnography and not sufficiently treated with NIV ventilation.
* the patient is diagnosed with obstructive sleep apnea and not sufficiently treated with NIV ventilation.
* the patient cannot meet the requirements of the study, according to the investigator.
* the patient is unable to complete a 6-minute walking test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04052958
Study Brief:
Protocol Section:
NCT04052958