NCT06677151 · University of Michigan
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Within 3 months of initiating CPAP use, and actively using CPAP
- Supraglottic airway collapse
- Distal airway stenosis
- Tracheobronchomalacia
- Currently pregnant
- Active COVID-19 infection
- Need for anticoagulative therapy
- Severe nasal allergies
- Bleeding disorder
- More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time
- Restrictive thoracic disorders
- Silicone, lidocaine, neosynephrine allergy
- Recurrent epistaxis
- Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure
Where
- Ann Arbor, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations