NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Capacity and willingness to sign consent
• Patient willingness to commit to and complete study over a 30-day time period
• Confirmed diagnosis of moderate to severe OSA (AHI \>= 15)
• OSA caused by upper airway obstruction
• CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
• Adequate manual dexterity to demonstrate ability to self-insert and remove device
Locations
United States
Michigan
Michigan Medicine
RECRUITING
Ann Arbor
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Zahra Nourmohammadi, PhD
znourmoh@med.umich.edu
734 936-9816
Backup
Louise M O'Brien, PhD
louiseo@med.umich.edu
734 647-9064
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2026-03
Participants
Target number of participants: 20
Treatments
Experimental: Nasopharyngeal airway device
A nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device will be used for one night in a sleep laboratory and 30 days at home.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: Wallace H Coulter Center for Translational Research