About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Within 3 months of initiating CPAP use, and actively using CPAP
Supraglottic airway collapse
Distal airway stenosis
Tracheobronchomalacia
Trial design
Single group
Treatments tested in this trial
nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device
DeviceThe 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.
Treatment groups
Trial 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.
Sponsors and contacts
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University of Michigan
Lead sponsor
Wallace H Coulter Center for Translational Research
Collaborator