NPA-OSA device tolerability, usability, and acclimation in adults with obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study asks adults with moderate-to-severe OSA to use a nasopharyngeal airway (NPA-OSA) device over a 30-day period to measure tolerability, usability, acclimation, and changes in apnea frequency. Eligible participants must have OSA from upper airway obstruction, be CPAP non-compliant or seeking an alternative, and be able to self-insert and remove the device. Outcomes include apnea-hypopnea index (AHI) changes, device tolerability, and user-reported usability, with exclusions for conditions that increase risk such as supraglottic collapse, severe nasal disease, bleeding disorders, pregnancy, active COVID-19, need for anticoagulation, or significant CO2 retention. The trial is conducted through Michigan Medicine with in-person visits for fitting and follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Michigan Medicine
  Ann Arbor, Michigan, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Louise M O'Brien, PhD — University of Michigan
• Study coordinator: Zahra Nourmohammadi, PhD
• Email: znourmoh@med.umich.edu
• Phone: 734 936-9816

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.