Philadelphia, Pennsylvania 19104

  • Organic Pediatric Obstructive Sleep Apnea

Purpose:

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.


Study summary:

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.


Criteria:

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 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.


Study is Available At:


Original ID:

12-008691


NCT ID:

NCT01768065


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

5 Years


Maximum Age:

16 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital of Philadelphia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carole Marcus
Principal Investigator
Children's Hospital of Philadelphia

Study Dates

Start Date:July 2012
Completion Date:April 2013
Completion Type:Actual
Primary Completion Date:April 2013
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 6, 2019
First Received Date:January 10, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Adherence using daily logs
Time Frame:One month
Safety Issues:False
Description:Adherence with using devices will be determined by daily logs and collecting used devices
Outcome Type:Primary Outcome
Measure:Apnea hypopnea index
Time Frame:Approximately one week
Safety Issues:False
Description:The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights

Study Interventions

Intervention Type:Device
Name:placebo sham
Arm Name:placebo sham
Intervention Type:Device
Name:Nasal Expiratory Positive Airway Pressure Device
Description:assigned to Nasal Expiratory Positive Airway Pressure arm
Arm Name:Nasal Expiratory Positive Airway Pressure Devices

Study Arms

Study Arm Type:Sham Comparator
Arm Name:placebo sham
Description:A sham device
Study Arm Type:Experimental
Arm Name:Nasal Expiratory Positive Airway Pressure Devices
Description:Nasal Expiratory Positive Airway Pressure Device

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital of Philadelphia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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