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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Completed

CT.gov ID

NCT01768065

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Organic Pediatric Obstructive Sleep Apnea	Device: Nasal Expiratory Positive Airway Pressure Device Device: placebo sham	Early Phase 1

Detailed Description

The nasal expiratory positive airway pressure (NEPAP) device has been used to treat OSAS in adults. A disposable device is placed in each nostril at night and attached with adhesive. The device acts as a one-way valve, during inspiration the valve opens, with negligible resistance to flow. During expiration, the valve closes and airflow is directed through small air channels, increasing resistance. The increased resistance helps to maintain the upper airway pressure during the critical end-expiratory period when the upper airway has been found to be most narrow in the breaths preceding an apnea event. In contrast to Continuous Positive Airway Pressure (CPAP) which provides positive pressure during both inspiration and expiration, NEPAP creates pressure during expiration. NEPAP is a potential alternative therapy which is less cumbersome than CPAP and may increase adherence.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nasal Expiratory Positive Airway Pressure Devices Nasal Expiratory Positive Airway Pressure Device	Device: Nasal Expiratory Positive Airway Pressure Device assigned to Nasal Expiratory Positive Airway Pressure arm
Sham Comparator: placebo sham A sham device	Device: placebo sham

Arm

Intervention/Treatment

Experimental: Nasal Expiratory Positive Airway Pressure Devices

Nasal Expiratory Positive Airway Pressure Device

Device: Nasal Expiratory Positive Airway Pressure Device

assigned to Nasal Expiratory Positive Airway Pressure arm

Sham Comparator: placebo sham

A sham device

Device: placebo sham

Outcome Measures

Primary Outcome Measures

Apnea hypopnea index [Approximately one week]
The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights

Secondary Outcome Measures

Adherence using daily logs [One month]
Adherence with using devices will be determined by daily logs and collecting used devices

Other Outcome Measures

Quality of life [One Month]
The Pediatric Quality of Life (PedsQL) score will be compared at baseline and after one month of device usage

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.