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:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT03312361
Eligibility Criteria:
Inclusion Criteria:
* individuals with a confirmed diagnosis of NMD
* age ≥ 5 years of age
* absence of hypoxia at rest, defined as oxygen saturation ≥ 92% for two consecutive minutes while at rest and breathing room air
* absence of daytime hypercapnea at rest, defined by partial pressure of carbon dioxide (pCO2) less than 45 mmHg on capillary or arterial blood gas at rest
* patient or authorized substitute decision maker provides consent to study participation.
Exclusion Criteria:
* current respiratory tract infection
* inability to comply with the study procedures
* severe heart failure as defined by uncontrolled symptoms of heart failure, or left ventricular ejection fraction \< 30%
* presence of a tracheostomy
* use of domiciliary bilevel positive airway pressure (BPAP) for more than 12 hours daily
* recent hospital admission within the past 4 weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT03312361
Study Brief:
Protocol Section:
NCT03312361