NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06677151
Status
Recruiting
Apply to this trial

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 pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.

Key Dates

Start date
Mar 7, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

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 one night in a sleep laboratory and 30 days at home.

Primary Outcome Measure

Change in severity of apnea hypopnea index (AHI) [ Time Frame: Baseline (day 0), 30 days ]

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 (SUB_INVESTIGATOR)
Jeff Plott, PhD (SUB_INVESTIGATOR)

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By research site
Michigan Medicine· Ann Arbor, MIUniversity of Michigan· Ann Arbor, MI

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