Long-term Evaluation of a Nasopharyngeal Airway

University of Michigan

Status: Enrolling

Conditions: Sleep Apnea, Obstructive

Treatments: Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device

Study type: Interventional

Funder types: Other

Identifiers

NCT07191314

HUM00274782

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Nasopharyngeal airway device

Experimental group

Description:

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

Treatment:

Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device