Obstructive Sleep ApneaNCT05527652
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
A study testing Self-Supporting Nasopharyngeal Airway (ssNPA) in people with Obstructive Sleep Apnea and Hypertonia, Muscle, run by University of Michigan at 1 site in United States.
Trial summary
The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO). Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction
- What is being tested?
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to Aug 2027
- Phase
- Interventional
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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index [AHI]>10 or AHI>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry [SpO2] nadir <=75%).
- All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
- Post adenotonsillectomy or those with contraindications to tonsillectomy.
- Tonsil size 2+ or smaller.
- Parent/caregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.
Who cannot join
- AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI<5 with hypoxemia.
- Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable
- Active Coronavirus (COVID) 19 infections
- End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time on PSG
- Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit/Hyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.
- Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)
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- Moderate/severe tracheobronchomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Michigan
Ann Arbor, Michigan, 48109
Louise M O'Brien, PhD, 734-647-9064, louiseo@med.umich.edu
David Zopf, MD
About this study
The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).
- Conditions
- Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction, Tolerance, Trisomy 21, Down Syndrome
- Being tested
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Keywords
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypertonia, Muscle, Apnea, Respiration Disorders, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Neuromuscular Manifestations, Neurologic Manifestations
- Medical subject headings
- Sleep Apnea, Obstructive, Muscle Hypertonia, Nasal Obstruction, Down Syndrome, Sleep Apnea Syndromes, Apnea, Respiration Disorders, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Supporting Nasopharyngeal Airway (ssNPA)Device
The ssNPA device is made of a single piece of flexible, medical-grade silicone. It is inserted through one nostril and extends to the anatomic position bypassing the upper airway obstruction above the epiglottis.
| Study group | Role | What they receive |
|---|---|---|
| Self-Supporting Nasopharyngeal Airway (ssNPA) | Experimental | Not described Receives: Device: Self-Supporting Nasopharyngeal Airway (ssNPA) |
| Standard of Care | No intervention | Waitlist control group: While waiting, participants will continue to receive the treatment they would have had before which will likely include being placed on the waiting list for positive airway pressure (PAP). After a period of being on the waitlist (8 weeks) there is an option to cross-over to the device arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Measured during the polysomnogram
Measured: Up to 16 weeks
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance
Measured by self report. Likert scale 0-5 (higher score is better)
Measured: Up to 16 weeks
Secondary outcomes (4)
Sleep quality
Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Measured: Up to 16 weeks
Snoring frequency
As reported by participant/care taker in survey given daily. Snoring frequency is rated on a Likert scale 1-5 where 5 indicates snoring more frequently.
Measured: Up to 16 weeks
Daytime sleepiness
Measured using the children's Epworth Sleepiness Scale - The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Measured: Up to 16 weeks
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.
There are several dimensions of the PedsQL: Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. Each domain will be scored on a scale of 0 (never have problems) to 4 (almost always have problems) and transformed on a scale of 0-100 by reverse scoring (0=100, 1=75, 2=50, 3=25, 4=0). Psychosocial Health Summary Score is the sum of the items over the number of items answered in the Emotional, Social, and School Functioning scales. Physical Health Summary Score is the Physical Functioning Scale Score. The total quality of life score is the sum of all the items over the number of items answered on all scales.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start16 Nov 2022
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized 1:1 to receive (1) immediate therapy with the ssNPA device or (2) a waitlist control group who will receive standard of care (SoC) for the first 8 weeks and then be offered the ssNPA at week 8 for the rest of the study period (till week 16).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Louise O'Brien, University of Michigan
- Investigators
- David A Zopf, MD, Principal investigator, The University of WisconsinLouise M O'Brien, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527652
- Sponsor's protocol ID
- HUM00220966
- Other IDs
- 1R61HL151952
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No