Long-term Evaluation of a Nasopharyngeal Airway

Not Applicable

Not yet recruiting

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT07191314
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in severity of apnea hypopnea index (AHI)	Baseline (day 0), 24 months	The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.

Trial Locations

Locations (2)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States