Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

Not Applicable

• Conditions: Hypotonia, Muscle; Obstructive Sleep Apnea; Nasal Airway Obstruction
• Interventions: Device: Self-Supporting Nasopharyngeal Airway (ssNPA)

• Registration Number: NCT06614582
• Lead Sponsor: University of Michigan

Brief Summary

This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a treatment for obstructive sleep apnea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-26
• Study Start: 2024-10-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

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

Inclusion Criteria

• Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials)
• Willingness to continue device usage.
• Confirmed diagnosis of OSA (apnea/hypopnea index; AHI > 10 or AHI >5 with lowest oxygen level ≤75%)
• At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors)
• Previous adenotonsillectomy (unless tonsillectomy not possible)
• Tonsil size 2+ or smaller

Exclusion Criteria

• Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above
• Any medical reason why ssNPA therapy may not be suitable
• Active COVID 19 infections Moderate/severe tracheobronchomalacia
• Need for anticoagulative therapy
• Bleeding disorder
• Restrictive thoracic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self-Supporting Nasopharyngeal Airway (ssNPA)	Self-Supporting Nasopharyngeal Airway (ssNPA)	Participants will use the device up to 24 months.

Primary Outcome Measures

Name	Time	Method
Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography	Approximately 1 year	Device efficacy will be measured by apnea/hypopnea index.
Long term device tolerability assessed by self-report from caregivers	2 years	This is a one question (likert scale 1-10) that participants\' caregivers will complete at the final assessment (higher scores indicating better device tolerability).

Secondary Outcome Measures

Name	Time	Method
Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality	1-2 years	This will be a on a scale 1-10 (higher score is better).
Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)	1-2 years	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 receive 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score).
Long-term impact on quality of life will be assessed with the OSA-18	1-2 years	This is an obstructive sleep apnea-specific quality of life tool for children and the Pediatric Quality of Life Inventory (PedsQL), a standard health-related quality of life instrument. Scores range from 0-126 with higher scores indicting worse impact. 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.
Family Impact Questionnaire (FIQ)	1-2 years	This tool measures parent's perceptions of the child's negative impact on the family. The FIQ is a 50-item, four-point Likert scale ranging from 0 (not at all) to 3 (very much) that asks about the impact the child has had on the family (e.g., social life, finances, marriage, and siblings) compared to the impact other children his/her age have on their families. Higher score is more significant impact.

Trial Locations

Locations (1)

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