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

Not Applicable

Recruiting

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

• Registration Number: NCT05527652
• Lead Sponsor: University of Michigan

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-02
• Study Start: 2022-11-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Supporting Nasopharyngeal Airway (ssNPA)	Self-Supporting Nasopharyngeal Airway (ssNPA)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Snoring frequency	Up to 16 weeks	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.
Quality of life as indicated by the dimensions of the PedsQL (pediatric quality of life) instrument.	Up to 16 weeks	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.
Sleep quality	Up to 16 weeks	Higher score in parent report of sleep quality on scale 0-5 (higher score is better)
Daytime sleepiness	Up to 16 weeks	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).

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States