Long-term Evaluation of a Nasopharyngeal Airway
NCT07191314 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-11-06
Summary
This long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151).
During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). At 12 months, participants will complete sleep questionnaires as part of this long-term follow-up period.
Conditions
- Sleep Apnea, Obstructive
Interventions
- DEVICE
-
nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device
The NPA-OSA is a flexible, medical-grade silicone, tube-like device that is self-inserted into the user's nasopharyngeal airway through one nostril prior to sleep and worn throughout the night to reduce or alleviate snoring and obstructive sleep apnea.
Sponsors & Collaborators
-
Wallace H Coulter Center for Translational Research
collaborator OTHER - lead OTHER
Principal Investigators
-
Louise M O'Brien, PhD · University of Michigan
-
David Zopf, MD, MS · University of Wisconsin, Madison
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-21
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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