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Enrolling by Invitation

NCT Number: NCT06614582

Long-term Evaluation of Nasopharyngeal Airway in Hypotonia

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.

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Key information

Conditions

Hypotonia, Muscle Abnormalities, Multiple Airway Obstruction Apnea Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Dyspnea Dyssomnias Genetic Diseases, Inborn Intellectual Disability Muscle Hypotonia Nasal Airway Obstruction Nasal Obstruction Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Manifestations Nose Diseases Obstructive Sleep Apnea Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

3 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Supporting Nasopharyngeal Airway (ssNPA)

Device

The ssNPA device is a flexible, medical-grade silicone, nasal tube that is self-inserted into the airway through one nostril and worn during the night. It can also be used during the day. The device works by supporting collapsed airway muscles and keeping the airway open.

In addition to wearing the device, study team members will call monthly and collect certain data, and medical information and participants will be asked to have a sleep study at the 12-month visit.

Primary outcomes

  1. Obstructive sleep apnea (OSA) severity measured by the apnea/hypopnea index (AHI) assessed by overnight polysomnography

    Time frame: Approximately 1 year

    Device efficacy will be measured by apnea/hypopnea index.

  2. Long term device tolerability assessed by self-report from caregivers

    Time frame: 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 outcomes

  1. Long-term impact on sleep quality will be assessed by the mean score on the parent report of sleep quality

    Time frame: 1-2 years

    This will be a on a scale 1-10 (higher score is better).

  2. Long-term impact on daytime sleepiness will be assessed by the mean score on the children's Epworth Sleepiness Scale (ESS)

    Time frame: 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).

  3. Long-term impact on quality of life will be assessed with the OSA-18

    Time frame: 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.

  4. Family Impact Questionnaire (FIQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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