NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep … (NCT06677151) | Clinical Trial Compass
RecruitingNot Applicable
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
United States20 participantsStarted 2025-03-07
Plain-language summary
This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.
Who can participate
Age range18 Years
SexALL
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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