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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carole Marcus, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01768065
First received: January 10, 2013
Last updated: June 18, 2013
Last verified: June 2013
  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.


Condition Intervention Phase
Organic Pediatric Obstructive Sleep Apnea
Device: Nasal Expiratory Positive Airway Pressure Device
Device: placebo sham
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Apnea hypopnea index [ Time Frame: Approximately one week ] [ Designated as safety issue: Yes ]
    The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights


Secondary Outcome Measures:
  • Adherence using daily logs [ Time Frame: One month ] [ Designated as safety issue: No ]
    Adherence with using devices will be determined by daily logs and collecting used devices


Other Outcome Measures:
  • Quality of life [ Time Frame: One Month ] [ Designated as safety issue: No ]
    The Pediatric Quality of Life (PedsQL) score will be compared at baseline and after one month of device usage


Enrollment: 15
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768065

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Carole Marcus Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Carole Marcus, Director, Sleep Center, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01768065     History of Changes
Other Study ID Numbers: 12-008691
Study First Received: January 10, 2013
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
NEPAP
CPAP
alternative
OSAS

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014