Long-term Evaluation of a Nasopharyngeal Airway

N/ARecruitingNCT07191314

University of Michigan20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Michigan Medicine

Ann Arbor, Michigan, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline (day 0), 24 months

Central Contacts

Zahra Nourmohammadi, PhD

CONTACT

734 936-9816 znourmoh@med.umich.edu

Louise M O'Brien, PhD

CONTACT

734 647-9064 louiseo@med.umich.edu

Data from ClinicalTrials.gov

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