NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
NCT ID: NCT06677151
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-03-07
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nasopharyngeal airway device
A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Wallace H Coulter Center for Translational Research
OTHER
University of Michigan
OTHER
Responsible Party
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Louise O'Brien
Professor, Sleep Medicine
Principal Investigators
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Louise M O'Brien, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Michigan Medicine
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00179497
Identifier Type: -
Identifier Source: org_study_id
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