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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT03449550
Eligibility Criteria:
Inclusion Criteria:
* Children between 2 and 14 years of age of both sexes consecutively assessed for clinical suspicion of OSA, defined as: snoring children with observed respiratory and / or apnea pauses and / or ventilatory effort during observed sleep, and who were asked for a sleep test
* Written informed consent signed.
Exclusion Criteria:
* Place of residence more than 100 km from the hospital
* Psychophysical incapacity to perform the study at home
* Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
* Children with chronic insomnia and / or depressive syndrome
* Children with malformative syndromes, Down Syndrome and neuromuscular diseases
* Complete or near complete nasal obstruction that prevents obtaining a quality signal with the HRP
* History of surgery and / or previous Positive continuous pressure (CPAP) for OSA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
14 Years
Study:
NCT03449550
Study Brief:
Protocol Section:
NCT03449550