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Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA

This study has been completed.
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Carole Marcus, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00458406
First received: April 6, 2007
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

Context: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is the usual treatment for children who do not improve following surgery. However, CPAP is uncomfortable and is often not tolerated. We therefore plan to study a modification of bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable.

Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex results in improvement in adherence as compared to CPAP. The secondary objective is to determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and determining which parameters predict adherence.

Study Design/Setting/Participants: A single center, randomized controlled double-blind study of Bi-Flex vs CPAP use in children with OSAS over a 3 month period.

Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study results, subjective questionnaire results. .


Condition Intervention
Obstructive Sleep Apnea
 Device: Bi-Flex vs. CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Adherence and Therapeutic Effectiveness of BiPAP With Bi-Flex Versus CPAP in Children With Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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

Primary Outcome Measures:
  • hours of use per night over three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drop out rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • AHI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • OSA 18 score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • NOSE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • PedQL [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bi-Flex
Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
 Device: Bi-Flex vs. CPAP
positive pressure used during sleep for 3 months
Other Names:
  • Bi-Flex
  • CPAP
Active Comparator: CPAP
Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
 Device: Bi-Flex vs. CPAP
positive pressure used during sleep for 3 months
Other Names:
  • Bi-Flex
  • CPAP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged 2 to 16 years.
  2. OSAS diagnosed on polysomnography.
  3. Positive airway pressure therapy indicated by patient's physician because surgery was either contraindicated or ineffective.
  4. No plans for upper airway surgery in the next 3 months.

Exclusion Criteria:

  1. Age less than 2 years, as infants and toddlers have different pulmonary mechanics from older children, and may require intense behavioral modification programs prior to CPAP use.
  2. Age greater or equal to 16 years, as results may be similar to adult studies in these older patients.
  3. Previous use of CPAP / bilevel ventilation.
  4. Unable to read / understand English. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458406

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Children's Hospital of Philadelphia
Philips Respironics
Investigators
Principal Investigator: Carole L Marcus, M.B.B.Ch. Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional 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: NCT00458406     History of Changes
Other Study ID Numbers: 2007-1-5190
Study First Received: April 6, 2007
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
obstructive sleep apnea
child
CPAP

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 May 21, 2013