Long-term Evaluation of a Nasopharyngeal Airway

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07191314
Status
Recruiting
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Conditions

  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device — 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.

Study Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nasopharyngeal airway device
    A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for two years at home.

Primary Outcome Measure

Change in severity of apnea hypopnea index (AHI) [ Time Frame: Baseline (day 0), 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Michigan MedicineAnn ArborMichigan48109
Zahra Nourmohammadi, PhD
[email protected]
Louise M O'Brien, PhD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Zahra Nourmohammadi
[email protected]
734 936-9816
Louise O'Brien, PhD (PRINCIPAL_INVESTIGATOR)
Jeff Plott, PhD (SUB_INVESTIGATOR)

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Michigan Medicine· Ann Arbor, MIUniversity of Michigan· Ann Arbor, MI

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