NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
Recruiting now · Not applicable
Conditions studied: Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT06677151
- Run by
- University of Michigan
- People needed
- 20
- Starts
- 2025-03-07
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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