Nasal Expiratory Positive Airway Pressure (NEPAP) for the Treatment of Pediatric Obstructive Sleep Apnea

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 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.

Inclusion Criteria:

1. 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)

2. OSAS (AHI > 5/hr)

3. Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy

4. Subject is non-adherent to CPAP or is seeking an alternative therapy

5. Tolerance of NEPAP device during a daytime session

6. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Severe developmental delay thought to involve a high risk of aspiration

2. Family does not understand English well enough to perform the standardized, validated
questionnaires.

3. Age >16 years since results may be similar to adult studies in these older patients.

4. Severe breathing disorder (including respiratory muscle weakness, bullous lung
disease, bypassed upper airway, pneumothorax, pneumomediastinum)

5. Severe heart disease (including heart failure)

6. 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 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.