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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Expiratory Positive Airway Pressure Devices | Experimental | Nasal Expiratory Positive Airway Pressure Device |
|
| placebo sham | Sham Comparator | A sham device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Expiratory Positive Airway Pressure Device | Device | assigned to Nasal Expiratory Positive Airway Pressure arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea hypopnea index | The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights | Approximately one week |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence using daily logs | Adherence with using devices will be determined by daily logs and collecting used devices | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The Pediatric Quality of Life (PedsQL) score will be compared at baseline and after one month of device usage | One Month |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Carole Marcus | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24932147 | Derived | Kureshi SA, Gallagher PR, McDonough JM, Cornaglia MA, Maggs J, Samuel J, Traylor J, Marcus CL. Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. J Clin Sleep Med. 2014 Jun 15;10(6):663-9. doi: 10.5664/jcsm.3796. |
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| placebo sham | Device |
|