Long-term Evaluation of a Nasopharyngeal Airway
ConditionSleep Apnea, Obstructive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
Trial design
Design model
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
20 Participants
are divided into 1 treatment groupGroup A: Nasopharyngeal airway deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Wallace H Coulter Center for Translational Research
Collaborator
Source ClinicalTrials.gov