We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768065
First Posted: January 15, 2013
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carole Marcus, Children's Hospital of Philadelphia
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 Carole Marcus, Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Apnea hypopnea index [ Time Frame: Approximately one week ]
    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 ]
    Adherence with using devices will be determined by daily logs and collecting used devices


Other Outcome Measures:
  • Quality of life [ Time Frame: One Month ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 10, 2013
First Posted: January 15, 2013
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Carole Marcus, 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 Wake Disorders
Nervous System Diseases