CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
ssNPAdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04846400
NCT04846400N/ACompleted
CompareCT.gov

Pilot Study of Novel Nasopharyngeal Airway Device for Treating Upper Airway Obstruction in Pediatric Hypotonia

University of Michigan·interventional·Posted Apr 15, 2021·Updated Dec 28, 2023

In Brief

A clinical study evaluating ssNPA for Sleep Apnea, Obstructive and 2 related conditions. Completed, enrolled 2 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Obstructive, Hypotonia, Child, Only
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 15, 2021
Enrollment StartSep 1, 2021
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.2 years ago

Interventions

ssNPAdevice

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