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

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 Overview

• Status: Completed
• Conditions: Organic Pediatric Obstructive Sleep Apnea
• Intervention / Treatment: Device: Nasal Expiratory Positive Airway Pressure Device; Device: placebo sham

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence using daily logs	Adherence with using devices will be determined by daily logs and collecting used devices	One month

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Carole Marcus, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: CPAP; alternative; OSAS; NEPAP
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 12-008691