Sleep Apnea, Obstructive
Conditions
Keywords
nasopharyngeal
Brief summary
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
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
University of Michigan
Wallace H Coulter Center for Translational Research
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in severity of apnea hypopnea index (AHI) | Baseline (day 0), 30 days | The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. |
Countries
United States
Contacts
CONTACTZahra Nourmohammadi, PhD
CONTACTLouise M O'Brien, PhD
PRINCIPAL_INVESTIGATORLouise M O'Brien, PhD
University of Michigan
Outcome results
None listed