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

Recruiting

NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: University of Michigan · Participants: 20 · Started: Mar 7, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06677151

Locations in the U.S.

MichiganMichigan Medicine, Ann Arbor
University of Michigan, Ann Arbor

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.