Long-term Evaluation of a Nasopharyngeal Airway

NCT ID: NCT07191314

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

nasopharyngeal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasopharyngeal airway device

A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for two years at home.

Group Type EXPERIMENTAL

nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wallace H Coulter Center for Translational Research

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Louise O'Brien

Professor, Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louise M O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

David Zopf, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michigan Medicine

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zahra Nourmohammadi, PhD

Role: CONTACT

Phone: 734 936-9816

Email: [email protected]

Louise M O'Brien, PhD

Role: CONTACT

Phone: 734 647-9064

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zahra Nourmohammadi, PhD

Role: primary

Zahra Nourmohammadi

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUM00274782

Identifier Type: -

Identifier Source: org_study_id