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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT03510403
Eligibility Criteria:
Inclusion Criteria:
* Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5\<AHI)
* BMI≤30kg/m²
* Patient with good motivation to use the nasal device,
* Informed consent signed,
* Patient with social protection.
Exclusion Criteria:
* Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
* Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
* Patient with one or more documented contraindication to use Nastent™,
* no regular partner,
* contraindication for sleep endoscopy,
* Psychiatric or neurological disorders (epilepsy),
* Progressive cancer or chronic inflammatory disease,
* AHI including more than 5 central apnea per hour,
* Allergy to one component of Nastent™.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03510403
Study Brief:
Protocol Section:
NCT03510403