ssNPA: Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04846400

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arm

4.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Hypotonia Child, Only	Device: ssNPA	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Novel Nasopharyngeal Airway Device for Treating Upper Airway Obstruction in Pediatric Hypotonia

Actual Study Start Date :

May 6, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ssNPA self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks.	Device: ssNPA The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA

Arm

Intervention/Treatment

Experimental: ssNPA

self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks.

Device: ssNPA

The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA

Outcome Measures

Primary Outcome Measures

Ability to tolerate [8 weeks]
Score of >=7 on Likert scale 0-10 in at least 60% of participants (higher score is better)
Comfort [8 weeks]
Score of >=6 on Likert scale 0-10 in at least 60% of participants (higher score is better)
Ease of use [8 weeks]
Score of >=5 on Likert scale 0-10 in at least 60% of participants (higher score is better)

Secondary Outcome Measures

Snoring [8 weeks]
Less frequent snoring
Daytime sleepiness [8 weeks]
Reduction in Epworth Sleepiness Scale score (0-24; lower score is better)
Sleep quality [8 weeks]
Higher score in parent report of sleep quality on scale 0-10 (higher score is better)
Device design [8 weeks]
Device optimization and manufacturing in a clean/sterile manner in 100% of cases
Insertion protocol [8 weeks]
Optimize insertion protocol with ease of insertion >= 5 on Likert scale of 1-10 in 60% of participants (higher score is better)

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

hypotonia
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)

Exclusion Criteria:

AHI <10
any reason why ssNPA may not be suitable
Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible
Safe Continuous positive airway pressure therapy (CPAP) use is possible and tolerated
Supraglottic airway collapse
Distal airway stenosis
Tracheobronchomalacia
Active COVID 19 infection
Need for anticoagulative therapy
Bleeding disorder
More than mild elevation of end tidal carbon dioxide (ETCO2) or transcutaneous carbon dioxide (TCO2) values >60 mmHg for >10% of sleep time
Restrictive thoracic disorders
Silicone, lidocaine, neosynephrine allergy