Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

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).

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Down Syndrome; Tolerance; Trisomy 21; Hypertonia, Muscle; Nasal Airway Obstruction
• Intervention / Treatment: Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Zopf, MD; Phone Number: 734-233-4122; Email: davidzop@med.umich.edu
• Study Contact Backup: Name: Louise O'Brien, PhD; Phone Number: 7342722783; Email: louiseo@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • The University of Michigan
      • Contact: David Zopf, MD; Phone Number: 734-233-4122; Email: davidzop@med.umich.edu
      • Principal Investigator: David Zopf, MD
      • Principal Investigator: Louise O'Brien, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)
• Moderate/severe tracheobronchomalacia
• Need for anticoagulative therapy
• Bleeding disorder
• Restrictive thoracic disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Supporting Nasopharyngeal Airway (ssNPA)	Device: Self-Supporting Nasopharyngeal Airway (ssNPA); 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.
No Intervention: Standard of Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index (AHI)	Measured during the polysomnogram	Up to 16 weeks
Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance	Measured by self report. Likert scale 0-5 (higher score is better)	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Higher score in parent report of sleep quality on scale 0-5 (higher score is better)	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.	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).	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.	Up to 16 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: David Zopf, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Nervous System Diseases; Sleep Apnea, Obstructive; Neurologic Manifestations; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Apnea; Respiration Disorders; Hypertonia, Muscle; Dyssomnias; Sleep Wake Disorders; Neuromuscular Manifestations
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Intellectual Disability; Nose Diseases; Respiratory Insufficiency; Abnormalities, Multiple; Chromosome Disorders; Chromosome Aberrations; Aneuploidy; Chromosome Duplication; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Airway Obstruction; Down Syndrome; Muscle Hypertonia; Nasal Obstruction; Trisomy; Muscle Hypotonia
• Other Study ID Numbers: HUM00220966; 1R61HL151952 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No