Sleep Apnea, ObstructivessNPANCT04846400
Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia
A study testing ssNPA in people with Sleep Apnea, Obstructive and Hypotonia, run by University of Michigan at 1 site in United States.
Trial summary
Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Hypotonia, Child, Only
- What is being tested?
- ssNPA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Aug 2022
- 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 HUAO: This includes those who newly diagnosed with OSA. These children will undergo overnight polysomnography to determine the presence of OSA (AHI>10 or AHI>5 with nocturnal hypoxemia defined as SpO2 nadir <=75%).
- Obstructive sleep apnea on polysomnogram with AHI>=10
- Presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
- Post adeonotonsillectomy or those with contraindications to tonsillectomy.
- obstructive sleep apnea on polysomnogram with AHI>=10
- 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 without hypoxemia or AHI<5 with hypoxemia - any reason why ssNPA may not be suitable
- Any medical reason why ssNPA therapy may not be suitable
- Active COVID 19 infections
- ETCO2 or 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 tracheobroncomalacia
- Need for anticoagulative therapy
- Bleeding disorder
- Restrictive thoracic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Pilot Study of Novel Nasopharyngeal Airway Device for Treating Upper Airway Obstruction in Pediatric Hypotonia
Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence. The multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.
Read the detailed description
There is a critical need for safe and effective treatment options for persistent obstructive sleep apnea (OSA) in patients with Hypotonic Upper Airway Obstruction (HUAO). HUAO encompass conditions such as cerebral palsy, hypoxic encephalopathy, syndromic tone anomalies, and neuromuscular disorders, and typically share a similar pattern of multisite upper airway collapse. OSA is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep with associated arousals and/ or oxygen desaturations. Of hypotonic patients with symptoms of sleep disordered breathing, one quarter have moderate OSA, and more than half have severe OSA. Thus, not only are patients more likely to have OSA, but it is likely to be much more severe. Currently available treatment options, ranging from palliative care to tracheostomy, often fail to fully meet the needs of these patients. The multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal airway stent that has demonstrated good tolerability in hypotonic patients. This initial phase will test an enhanced version of the device for acceptability and tolerability. Critically, insertion, adherence, and compliance protocols will be optimized for preparation of the full trial.
This record originally included the Secondary Outcome Measure "Device Design". This Secondary Outcome Measure was removed during the results reporting process upon advisement of ClinicalTrials.gov reviewers, as it was not a directly health-related outcome.
- Conditions
- Sleep Apnea, Obstructive, Hypotonia, Child, Only
- Being tested
- ssNPA
- Keywords
- Obstructive sleep apnea, Hypotonia, Nasal airway, Tolerability
- Medical subject headings
- Sleep Apnea, Obstructive, Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ssNPADevice
The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
| Study group | Role | What they receive |
|---|---|---|
| ssNPA | Experimental | self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks. Receives: Device: ssNPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Tolerate Measured by Percent of Participants With Protocol Goal
Protocol objective was to achieve a score of >=7 in at least 60% of participants. Score of >=7 on Likert scale 0-10 (higher score is better).
Measured: 8 weeks
Comfort as Measured by Percent of Participants With Protocol Objective Score
Protocol objective was to achieve a score of >=6 in at least 60% of participants. Score of >=6 on Likert scale 0-10 (higher score is better).
Measured: 8 weeks
Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal
Score of >=5 on Likert scale 1-10 (higher score is better).
Measured: 8 weeks
Secondary outcomes (4)
Snoring
Less frequent snoring, as measured by scores of 1 or 2 on a question that read: While using the device my child's snoring occurred:
1 much less often; 2: less often; 3: unchanged; 4: more often; 5: much more
Measured: 8 weeks
Change in Daytime Sleepiness as Shown by Number of Participants Who Had a Reduction in Their Epworth Sleepiness Scale Score
Reduction in Epworth Sleepiness Scale score (0-24; lower score is better);
Measured: 8 weeks
Sleep Quality, as Measured by Number of Participants With Parent Identified Improved Sleep
Number of participants whose parents' response on the sleep quality improvement question were >=7. Change in sleep quality was reported on a 1-10 scale, where 1 was greatest worsening of sleep and 10 was most improved sleep.
Measured: 8 weeks
Insertion Protocol Optimization as Measured by Percent of Participants Who Found Insertion Relatively Easy
Percent of participants who reported a score of <= 5 on Likert scale of 1-10, where lower score indicates easier insertion.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Sep 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 2 participants (actual)
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, David Zopf, University of Michigan
- Investigators
- David A Zopf, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846400
- Sponsor's protocol ID
- 1R61HL151952
- Other IDs
- R61HL151952
- Acronym
- ssNPA
- Status last verified
- Dec 2023
- First submitted
- 13 Apr 2021
- Last updated
- 28 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: For this initial pilot of 5 participants there are no plans to share data.