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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT06677151
Eligibility Criteria:
Inclusion Criteria:
* Capacity and willingness to sign consent
* Patient willingness to commit to and complete study over a 30-day time period
* Confirmed diagnosis of moderate to severe OSA (AHI \>= 15)
* OSA caused by upper airway obstruction
* CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
* Adequate manual dexterity to demonstrate ability to self-insert and remove device
Exclusion Criteria:
* Within 3 months of initiating CPAP use, and actively using CPAP
* Supraglottic airway collapse
* Distal airway stenosis
* Tracheobronchomalacia
* Currently pregnant
* Active COVID-19 infection
* Need for anticoagulative therapy
* Severe nasal allergies
* Bleeding disorder
* More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time
* Restrictive thoracic disorders
* Silicone, lidocaine, neosynephrine allergy
* Recurrent epistaxis
* Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06677151
Study Brief:
Protocol Section:
NCT06677151