Recruiting

NPA-OSA Device

Sponsor:

University of Michigan

Code:

NCT06677151

Conditions

Sleep Apnea, Obstructive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

Study Details

Brief 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.

Conditions

Sleep Apnea, Obstructive

Study ID

NCT06677151

Start date

Mar 7, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in severity of apnea hypopnea index (AHI) [ Time Frame: Baseline (day 0), 30 days ]

Central Contacts and Locations

Central contacts

Zahra Nourmohammadi, PhD

734 936-9816znourmoh@med.umich.edu

Louise M O'Brien, PhD

734 647-9064louiseo@med.umich.edu

Locations

Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Zahra Nourmohammadi, PhD

znourmoh@med.umich.edu

Principal Investigator:

Louise M O'Brien, PhD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Zahra Nourmohammadi

734 936-9816znourmoh@med.umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • nasopharyngeal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-12.