Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

NCT ID: NCT04846400

Last Updated: 2023-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-08-30

Brief Summary

Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence. The multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.

Detailed Description

There is a critical need for safe and effective treatment options for persistent obstructive sleep apnea (OSA) in patients with Hypotonic Upper Airway Obstruction (HUAO). HUAO encompass conditions such as cerebral palsy, hypoxic encephalopathy, syndromic tone anomalies, and neuromuscular disorders, and typically share a similar pattern of multisite upper airway collapse. OSA is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep with associated arousals and/ or oxygen desaturations. Of hypotonic patients with symptoms of sleep disordered breathing, one quarter have moderate OSA, and more than half have severe OSA. Thus, not only are patients more likely to have OSA, but it is likely to be much more severe. Currently available treatment options, ranging from palliative care to tracheostomy, often fail to fully meet the needs of these patients. The multidisciplinary team has developed a dramatically effective non-surgical nasopharyngeal airway stent that has demonstrated good tolerability in hypotonic patients. This initial phase will test an enhanced version of the device for acceptability and tolerability. Critically, insertion, adherence, and compliance protocols will be optimized for preparation of the full trial.

This record originally included the Secondary Outcome Measure "Device Design". This Secondary Outcome Measure was removed during the results reporting process upon advisement of ClinicalTrials.gov reviewers, as it was not a directly health-related outcome.

Conditions

Sleep Apnea, Obstructive; Hypotonia; Child, Only

Keywords

Obstructive sleep apnea; Hypotonia; Nasal airway; Tolerability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ssNPA

self-supporting nasopharyngeal airway to be used nightly for approximately 8 weeks.

Group Type: EXPERIMENTAL

ssNPA

Intervention Type: DEVICE

The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA

Interventions

ssNPA

The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children with HUAO: This includes those who newly diagnosed with OSA. These children will undergo overnight polysomnography to determine the presence of OSA (AHI>10 or AHI>5 with nocturnal hypoxemia defined as SpO2 nadir <=75%).
• Obstructive sleep apnea on polysomnogram with AHI>=10
• Presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive/inattentive behaviors)
• Post adeonotonsillectomy or those with contraindications to tonsillectomy.
• obstructive sleep apnea on polysomnogram with AHI>=10
• 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 without hypoxemia or AHI<5 with hypoxemia - any reason why ssNPA may not be suitable
• Any medical reason why ssNPA therapy may not be suitable
• Active COVID 19 infections
• ETCO2 or 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 tracheobroncomalacia
• Need for anticoagulative therapy
• Bleeding disorder
• Restrictive thoracic disorders

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

David Zopf

Assistant Professor of Otolaryngology-Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Zopf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R61HL151952

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R61HL151952

Identifier Type: NIH

Identifier Source: org_study_id

View Link