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NCT06677151NARecruiting

NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients

University of Michigan

Start Date

3/7/2025

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

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Conditions

Sleep Apnea, Obstructive

Locations

Michigan Medicine

Ann Arbor, Michigan 48109

United States

University of Michigan

Ann Arbor, Michigan 48109

United States