Sleep Apnea, ObstructiveNCT06677151
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
A study testing nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device in people with Sleep Apnea, Obstructive, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Within 3 months of initiating CPAP use, and actively using CPAP
- Supraglottic airway collapse
- Distal airway stenosis
- Tracheobronchomalacia
- Currently pregnant
- Active COVID-19 infection
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Michigan Medicine
Ann Arbor, Michigan, 48109
Zahra Nourmohammadi, PhD, znourmoh@med.umich.edu
Louise M O'Brien, PhD
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Zahra Nourmohammadi, 734 936-9816, znourmoh@med.umich.edu
Louise O'Brien, PhD
About this study
Official title: NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients
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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device
- Keywords
- nasopharyngeal
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal airway obstructive sleep apnea (NPA-OSA) deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal airway device | Experimental | A nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home. Receives: Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of apnea hypopnea index (AHI)
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
Measured: Baseline (day 0), 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start7 Mar 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Wallace H Coulter Center for Translational Research
- Responsible party
- Principal investigator, Louise O'Brien, University of Michigan
- Investigators
- Louise M O'Brien, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677151
- Sponsor's protocol ID
- HUM00179497
- Status last verified
- Mar 2026
- First submitted
- 4 Nov 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients
- ClinicalTrials.gov ID
- NCT06677151
- Acronym / sponsor ID
- HUM00179497
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- nasopharyngeal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Wallace H Coulter Center for Translational Research
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal airway device | Experimental | Device: nasopharyngeal airway obstructive sleep apnea (NPA-OSA) deviceA nasopharyngeal airway obstructive sleep apnea ("NPA"-OSA) device will be used for one night in a sleep laboratory and 30 days at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Within 3 months of initiating CPAP use, and actively using CPAP
- Supraglottic airway collapse
- Distal airway stenosis
- Tracheobronchomalacia
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal airway obstructive sleep apnea (NPA-OSA) deviceThe 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. | Device | Nasopharyngeal airway device |
Primary outcome
Change in severity of apnea hypopnea index (AHI)
Time frame: Baseline (day 0), 30 days
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise M O'Brien, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device in people with Sleep Apnea, Obstructive, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zahra Nourmohammadi, PhD (734 936-9816, znourmoh@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of apnea hypopnea index (AHI) (time frame: Baseline (day 0), 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.