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NCT01768065 · ClinicalTrials.gov registry record · Early Phase 1

Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

A Early Phase 1 study, sponsored by Children's Hospital of Philadelphia.

Completed
Registry status
Early Phase 1
Development phase
15
Enrollment target

NCT01768065: Completed Early Phase 1 study, sponsored by Children's Hospital of Philadelphia.

NCT01768065 is a Early Phase 1 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01768065, a Early Phase 1 study, has completed, sponsored by Children's Hospital of Philadelphia.

COMPLETED
Registry status
Early Phase 1
Development phase
15 participants
Enrollment target

Study Summary

This study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults.

Primary Outcome

The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights

Interventions

  • DEVICE Nasal Expiratory Positive Airway Pressure Device
  • DEVICE placebo sham

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2012-07
Est. Completion 2013-04
Phase Early Phase 1
Children's Hospital of Philadelphia

431 total trials

What the finished NCT01768065 record still lists

NCT01768065 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 2 interventions - of which Nasal Expiratory Positive Airway Pressure Device is the first listed.

NCT01768065 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01768065 about?

NCT01768065 is a clinical study titled "Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome". This study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults.

What is the current status of trial NCT01768065?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2012-07. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01768065?

The interventions under investigation include: Nasal Expiratory Positive Airway Pressure Device (DEVICE), placebo sham (DEVICE).

Who is sponsoring clinical trial NCT01768065?

This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01768065's enrollment target sits among peer trials

15 1403rd of 2000 higher than 527 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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 NCT01768065, the US trial registry maintained by the National Library of Medicine. NCT01768065 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.