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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527652
• Other study ID #: HUM00220966
• Secondary ID: 1R61HL151952
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: David Zopf, MD
• Phone: 734-233-4122
• Email: davidzop[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Down Syndrome
• Hypertonia, Muscle
• Muscle Hypertonia
• Muscle Hypotonia
• Nasal Airway Obstruction
• Nasal Obstruction
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Tolerance
• Trisomy 21

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index (AHI)	Measured during the polysomnogram	Up to 16 weeks
Primary	Self-Supporting Nasopharyngeal Airway (ssNPA) tolerance	Measured by self report. Likert scale 0-5 (higher score is better)	Up to 16 weeks
Secondary	Sleep quality	Higher score in parent report of sleep quality on scale 0-5 (higher score is better)	Up to 16 weeks
Secondary	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
Secondary	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
Secondary	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