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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Organic Pediatric Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01768065

Run by

Children's Hospital of Philadelphia

People needed

15

Starts

2012-07-01

Expected to finish

2013-04-01

Last updated by the study team

2019-09-10

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects age 5-16 years (note: Due to the size of the devices, it is expected that most children will be at least 8 years old, but a few may be younger. Subjects will be evaluated in clinic to fit for size and habituate to the device)
• OSAS (AHI > 5/hr)
• Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy
• Subject is non-adherent to CPAP or is seeking an alternative therapy
• Tolerance of NEPAP device during a daytime session
• Parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if…

• Severe developmental delay thought to involve a high risk of aspiration
• Family does not understand English well enough to perform the standardized, validated questionnaires.
• Age >16 years since results may be similar to adult studies in these older patients.
• Severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum)
• Severe heart disease (including heart failure)
• An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection or perforation of the ear drum
• Subjects that do not meet all of the enrollment criteria will not be enrolled. Any violations of these criteria will be reported in accordance with Institutional Review Board (IRB) Policies and Procedures.
• Study members will not recruit females who are known to be pregnant. However, if a subject becomes pregnant during the study, we will continue to use the device. Pregnancy is not an exclusion criterion as positive airway pressure therapy does not harm the pregnant woman or fetus.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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