Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT07191314

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 long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151).

During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). At 12 months, participants will complete sleep questionnaires as part of this long-term follow-up period.

Conditions

Sleep Apnea, Obstructive

Study ID

NCT07191314

Start date

Oct 21, 2025

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

-Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.

Exclusion Criteria:

  • The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.

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 two years 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), 24 months ]

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

Principal Investigator:

Louise O'Brien, PhD

More Information

Sponsor

University of Michigan

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

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 2025-11-06.