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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Capacity and willingness to sign consent
  • Patient willingness to commit to and complete study over a 30-day time period
  • Confirmed diagnosis of moderate to severe OSA (AHI >= 15)
  • OSA caused by upper airway obstruction
  • CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
  • Adequate manual dexterity to demonstrate ability to self-insert and remove device

Exclusion Criteria:

  • Within 3 months of initiating CPAP use, and actively using CPAP
  • Supraglottic airway collapse
  • Distal airway stenosis
  • Tracheobronchomalacia
  • Currently pregnant
  • Active COVID-19 infection
  • Need for anticoagulative therapy
  • Severe nasal allergies
  • Bleeding disorder
  • More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time
  • Restrictive thoracic disorders
  • Silicone, lidocaine, neosynephrine allergy
  • Recurrent epistaxis
  • Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure

Study details
    Sleep Apnea
    Obstructive

NCT06677151

University of Michigan

15 October 2025

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