Long-term Evaluation of a Nasopharyngeal Airway
1 other identifier
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2025
CompletedFirst Posted
Study publicly available on registry
September 24, 2025
CompletedStudy Start
First participant enrolled
October 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
November 6, 2025
November 1, 2025
1.9 years
September 17, 2025
November 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in severity of apnea hypopnea index (AHI)
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
Baseline (day 0), 24 months
Study Arms (1)
Nasopharyngeal airway device
EXPERIMENTALA nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for two years at home.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.
You may not qualify if:
- The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Michigan Medicine
Ann Arbor, Michigan, 48109, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise M O'Brien, PhD
University of Michigan
- PRINCIPAL INVESTIGATOR
David Zopf, MD, MS
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Sleep Medicine
Study Record Dates
First Submitted
September 17, 2025
First Posted
September 24, 2025
Study Start
October 21, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share