NCT06677151

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

November 4, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

March 7, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

November 4, 2024

Last Update Submit

March 10, 2026

Conditions

Sleep Apnea, Obstructive

Keywords

nasopharyngeal

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Nasopharyngeal airway device

EXPERIMENTAL

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

Interventions

nasopharyngeal airway obstructive sleep apnea (NPA-OSA) deviceDEVICE

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.

Nasopharyngeal airway device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Louise M O'Brien, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Nourmohammadi, PhD

CONTACT

734 936-9816znourmoh@med.umich.edu

Louise M O'Brien, PhD

CONTACT

734 647-9064louiseo@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Sleep Medicine

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 6, 2024

Study Start

March 7, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)