Sleep Apnea, ObstructiveNCT07191314
Long-term Evaluation of a Nasopharyngeal Airway
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 long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151). During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). 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
- 21 Oct 2025to Sep 2027
- 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
- -Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.
Who cannot join
- The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
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
This long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151).
During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). At 12 months, participants will complete sleep questionnaires as part of this long-term follow-up period.
- 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 two years 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), 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start21 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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 MichiganDavid Zopf, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191314
- Sponsor's protocol ID
- HUM00274782
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of a Nasopharyngeal Airway
- ClinicalTrials.gov ID
- NCT07191314
- Acronym / sponsor ID
- HUM00274782
- 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
- 21 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Sep 2025 (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 long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151).
During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). At 12 months, participants will complete sleep questionnaires as part of this long-term follow-up period.
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 two years at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.
Key exclusion criteria (1 listed)
- The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
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), 24 months
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 6 Nov 2025.
- 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
David Zopf, MD, MS principal investigator
University of Wisconsin, Madison
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 1 inclusion and 1 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 6 Nov 2025. 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), 24 months). 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 6 Nov 2025.