Long-term Evaluation of a Nasopharyngeal Airway

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine, Ann Arbor, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

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 outcomes

Change in severity of apnea hypopnea index (AHI)

Time frame: Baseline (day 0), 24 months

The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.

Study contacts

Contact information is provided by the study sponsor or research team.

Louise M O'Brien, PhD

CONTACT

[email protected]

734 647-9064

Zahra Nourmohammadi, PhD

CONTACT

[email protected]

734 936-9816

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

Wallace H Coulter Center for Translational Research

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 24, 2025
Registry last updated: Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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