Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

NCT04846400 | Completed Results DMC FDA Device

• 2 other identifiers: 1R61HL151952R61HL151952
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Hypotonia; Child, Only

Keywords

Obstructive sleep apnea; Hypotonia; Nasal airway; Tolerability

Outcome Measures

Primary Outcomes (3)

• Ability to Tolerate Measured by Percent of Participants With Protocol Goal

  Protocol objective was to achieve a score of \>=7 in at least 60% of participants. Score of \>=7 on Likert scale 0-10 (higher score is better).

  8 weeks

• Comfort as Measured by Percent of Participants With Protocol Objective Score

  Protocol objective was to achieve a score of \>=6 in at least 60% of participants. Score of \>=6 on Likert scale 0-10 (higher score is better).

  8 weeks

• Ease of Use as Indicated by Percent of Participants Whose Parents Responded Favorably to Device Use, With Protocol Goal

  Score of \>=5 on Likert scale 1-10 (higher score is better).

  8 weeks

Secondary Outcomes (4)

• Snoring

  8 weeks

• Change in Daytime Sleepiness as Shown by Number of Participants Who Had a Reduction in Their Epworth Sleepiness Scale Score

  8 weeks

• Sleep Quality, as Measured by Number of Participants With Parent Identified Improved Sleep

  8 weeks

• Insertion Protocol Optimization as Measured by Percent of Participants Who Found Insertion Relatively Easy

  8 weeks

Study Arms (1)

ssNPA

EXPERIMENTAL

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

Device: ssNPA

Interventions

ssNPA DEVICE

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

ssNPA

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Muscle Hypotonia

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David A Zopf, MD
• Organization: University of Michigan

davidzop@med.umich.edu

734-936-5730

Study Officials

• David A Zopf, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: September 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: December 28, 2023
• Results First Posted: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)