Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06677151

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

Led by University of Michigan · Updated on 2026-03-12

20

Participants Needed

2

Research Sites

90 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

W

Wallace H Coulter Center for Translational Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Capacity and willingness to sign consent
  • Willingness to complete the study over 30 days
  • Confirmed moderate to severe OSA with apnea hypopnea index (AHI) of 15 or greater
  • OSA caused by upper airway obstruction
  • Non-compliance with CPAP or interest in alternative therapy
  • Adequate manual dexterity to self-insert and remove the device
Not Eligible

You will not qualify if you...

  • Actively using CPAP within 3 months of starting it
  • Supraglottic airway collapse
  • Distal airway stenosis
  • Tracheobronchomalacia
  • Currently pregnant
  • Active COVID-19 infection
  • Need for anticoagulative therapy
  • Severe nasal allergies
  • Bleeding disorder
  • Elevated carbon dioxide levels during sleep (ETCO2 or TCO2 >60 mmHg for >10% of sleep time)
  • Restrictive thoracic disorders
  • Allergy to silicone, lidocaine, or neosynephrine
  • Recurrent nosebleeds (epistaxis)
  • Uncontrolled or serious illnesses including severe breathing disorders, severe heart disease, or pathologically low blood pressure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Michigan Medicine

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

2

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

Z

Zahra Nourmohammadi, PhD

CONTACT

L

Louise M O'Brien, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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