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NCT04846400 · ClinicalTrials.gov registry record · NA

Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

A NA study of Sleep Apnea, Obstructive and Child, Only, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
2
Enrollment target
1
Study location

NCT04846400: Completed NA study of Sleep Apnea, Obstructive and Child, Only, sponsored by University of Michigan.

NCT04846400 is a NA study of Sleep Apnea, Obstructive and Child, Only that has completed, run by University of Michigan. The registered enrollment target is 2 participants, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04846400, a NA study of Sleep Apnea, Obstructive and Child, Only, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
2 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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).

Interventions

  • DEVICE ssNPA

Study Locations (1)

Michigan

  • C.S. Mott Children's Hospital - Ann Arbor

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2021-09-01
Est. Completion 2022-08-30
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04846400 record still lists

NCT04846400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (99% lower).

The record links to 3 conditions, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 1 intervention - of which ssNPA is the first listed.

NCT04846400 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT04846400 about?

NCT04846400 is a clinical study titled "Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia". 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 multidisciplina...

What is the current status of trial NCT04846400?

This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2021-09-01. Estimated completion is 2022-08-30.

What conditions does trial NCT04846400 study?

This clinical trial studies the following conditions: Sleep Apnea, Obstructive, Child, Only, Hypotonia.

What interventions are being tested in trial NCT04846400?

The interventions under investigation include: ssNPA (DEVICE).

Who is sponsoring clinical trial NCT04846400?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04846400 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Sleep Apnea, Obstructive

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04846400's enrollment target sits among peer trials

2 46th of 45 the lowest of 45 other Sleep Apnea, Obstructive trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04846400, the US trial registry maintained by the National Library of Medicine. NCT04846400 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.