Long-term Evaluation of a Nasopharyngeal Airway
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device.
- Who it may be relevant to
- Registry conditions: Sleep Apnea, Obstructive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device
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.
Primary outcome measures
- Change in severity of apnea hypopnea index (AHI) [Time frame: Baseline (day 0), 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Michigan Medicine — Ann Arbor
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT07191314 · HUM00274782