NPA-OSA device tolerability, usability, and acclimation in adults with obstructive sleep apnea
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients
NA · University of Michigan · NCT06677151
This pilot will test whether a small nasopharyngeal airway (NPA-OSA) device can reduce apneas and be tolerated by adults with moderate to severe obstructive sleep apnea who are not using CPAP.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT06677151 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study asks adults with moderate-to-severe OSA to use a nasopharyngeal airway (NPA-OSA) device over a 30-day period to measure tolerability, usability, acclimation, and changes in apnea frequency. Eligible participants must have OSA from upper airway obstruction, be CPAP non-compliant or seeking an alternative, and be able to self-insert and remove the device. Outcomes include apnea-hypopnea index (AHI) changes, device tolerability, and user-reported usability, with exclusions for conditions that increase risk such as supraglottic collapse, severe nasal disease, bleeding disorders, pregnancy, active COVID-19, need for anticoagulation, or significant CO2 retention. The trial is conducted through Michigan Medicine with in-person visits for fitting and follow-up.
Who should consider this trial
Good fit: Adults with confirmed moderate-to-severe OSA (AHI ≥15) caused by upper airway obstruction who are CPAP non-compliant or seeking an alternative and who can self-insert the device and complete a 30-day protocol.
Not a fit: Patients with supraglottic airway collapse, distal airway stenosis, tracheobronchomalacia, severe nasal allergies or bleeding disorders, those on anticoagulation, pregnant people, active COVID-19 infection, or significant CO2 retention are unlikely to benefit.
Why it matters
Potential benefit: If successful, this device could provide a simple, lower-burden alternative to CPAP that reduces apnea events for some patients.
How similar studies have performed: Nasopharyngeal airway use for OSA is relatively novel with limited published data and no large randomized trials showing clear, generalizable benefit.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- Michigan Medicine — Ann Arbor, Michigan, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Louise M O'Brien, PhD — University of Michigan
- Study coordinator: Zahra Nourmohammadi, PhD
- Email: znourmoh@med.umich.edu
- Phone: 734 936-9816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, nasopharyngeal