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

Organic Pediatric Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768065
• Other study ID #: 12-008691
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: September 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Organic Pediatric Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Nasal Expiratory Positive Airway Pressure Device
assigned to Nasal Expiratory Positive Airway Pressure arm
• placebo sham

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	The Pediatric Quality of Life (PedsQL) score will be compared at baseline and after one month of device usage	One Month
Primary	Apnea hypopnea index	The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights	Approximately one week
Secondary	Adherence using daily logs	Adherence with using devices will be determined by daily logs and collecting used devices	One month