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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zahra Nourmohammadi, PhD; Phone Number: 734 936-9816; Email: znourmoh@med.umich.edu
• Study Contact Backup: Name: Louise M O'Brien, PhD; Phone Number: 734 647-9064; Email: louiseo@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Sub-Investigator: Louise O'Brien, PhD
      • Sub-Investigator: Jeff Plott, PhD
      • Contact: Zahra Nourmohammadi; Phone Number: 734 936-9816; Email: znourmoh@med.umich.edu
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Michigan Medicine
      • Contact: Zahra Nourmohammadi, PhD; Email: znourmoh@med.umich.edu
      • Principal Investigator: Louise M O'Brien, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasopharyngeal airway device; A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home.	Device: nasopharyngeal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in severity of apnea hypopnea index (AHI)	The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.	Baseline (day 0), 30 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Wallace H Coulter Center for Translational Research
• Investigators: Principal Investigator: Louise M O'Brien, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: nasopharyngeal
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: HUM00179497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No