NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
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 →
Unsure about the terms? Read our patient guide →
Official title
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients
Overview
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.
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), 30 days]
Eligibility criteria
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
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: NCT06677151 · HUM00179497