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

University of Michigan

Status: Enrolling

Conditions: Sleep Apnea, Obstructive

Treatments: Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

Study type: Interventional

Funder types: Other

Identifiers

NCT06677151

HUM00179497

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Nasopharyngeal airway device

Experimental group

Description:

A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home.

Treatment:

Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device