Long-term use of a nasopharyngeal airway for obstructive sleep apnea
Long-term Evaluation of a Nasopharyngeal Airway
This follow-up lets people who finished the parent trial keep using a nasopharyngeal airway to see how it works over the long term for obstructive sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT07191314 on ClinicalTrials.gov |
What this trial studies
This long-term follow-up allows participants from the parent trial to continue using a nasopharyngeal airway device for obstructive sleep apnea while remaining under study-team oversight. The study team will maintain contact as needed and participants will receive clinical follow-up with their own physicians. At 12 months participants will complete sleep questionnaires to document symptoms, device tolerability, and ongoing use. Participants who were non-compliant in the parent study are excluded and continued device use is voluntary.
Who should consider this trial
Good fit: Adults with obstructive sleep apnea who completed the parent NPA-OSA study, were compliant with the device, and wish to continue using it are ideal candidates.
Not a fit: Patients who were non-compliant with the device during the parent study or who cannot tolerate a nasopharyngeal airway are unlikely to benefit.
Why it matters
Potential benefit: If successful, continued device use could help maintain or improve sleep apnea symptoms and sleep quality without more invasive treatments.
How similar studies have performed: Short-term studies and the parent trial have shown some benefit with nasopharyngeal airway devices, but robust long-term evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device. Exclusion Criteria: * The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
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.