RecruitingNot ApplicableNCT06677151

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 Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients

Sponsor

University of Michigan

Enrollment

20 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Sleep Apnea, Obstructive

Summary

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria14

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

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Interventions

DEVICEnasopharyngeal airway obstructive sleep apnea (NPA-OSA) 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.