Sleep Apnea, Obstructive
Conditions
Keywords
nasopharyngeal
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.
Interventions
The 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.
Sponsors
Wallace H Coulter Center for Translational Research
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactZahra Nourmohammadi, PhD
Backup ContactLouise M O'Brien, PhD
Outcome results
None listed