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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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)
Show all 10Show fewer
  • 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

Other trials in United States

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.

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 groups in NCT04846400
Study groupRoleWhat they receive
ssNPAExperimentalself-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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted15 Apr 2021
  2. Study start1 Sep 2021
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

Resources

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)
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
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.

Questions about this trial

What is this clinical trial studying?

A study testing ssNPA in people with Sleep Apnea, Obstructive and Hypotonia, run by University of Michigan at 1 site 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 28 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability to Tolerate Measured by Percent of Participants With Protocol Goal (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04846400.

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 28 Dec 2023.

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