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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: March 31, 2014
Last verified: March 2014
  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
Device: 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:


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

Primary Outcome Measures:
  • Minutes of Use Per Night at Month 1 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The number of minutes of use per night at month 1.

  • Minutes of Use Per Night at Month 3 [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The number of minutes of use per night at Month 3.

  • Change in Minutes of Use Per Night From Month 1 to Month 3 [ Time Frame: month 1, month 3 ] [ Designated as safety issue: No ]
    minutes of use per night at Month 3 minus minutes of use per night at Month 1


Secondary Outcome Measures:
  • Drop Out Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of drop-outs included subjects in which investigators were unable to obtain a final download from the device.

  • Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in Apnea Hypopnea Index from Month 1 to Month 3. AHI at Month 3 minus AHI at Month 1.

  • Obstructive Sleep Apnea (OSA) 18 Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in ESS From Month 1 to Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in the Epworth Sleepiness Scale (ESS) score from Month 1 to Month 3: (Score at Month 3 minus Score at Month 1). The ESS measures daytime sleepiness in certain situations e.g. sitting/reading, watching television, sitting inactive in public, as a passenger in a car for an hour without a break, lying down to rest in the afternoon when circumstances permit, sitting/talking with someone, sitting quietly after lunch, or in a car, while stopped for a few minutes in traffic. The scale ranges from a minimum of zero to 24, with higher scores indicating greater daytime sleepiness.

  • Change in NOSE Scale Score From Month 1 to Month 3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in the total Nasal Obstruction Symptom Evaluation (NOSE) scale score (Score at Month 3 minus Score at Month 1). This scale evaluates the severity of nasal obstructive symptoms. The scale ranges from 0-20, with a higher score indicating more nasal obstruction.

  • Pediatric Quality of Life (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. Following a baseline polysomnography, subjects in this arm will undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.

In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea will be randomized to Bi-Flex or CPAP, and repeat polysomnography will be performed on pressure at 3 months. Objective adherence data will be obtained at 1 and 3 months.

Device: Bi-Flex

Bi-Flex: Subjects in this arm undergo bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.

Positive pressure used during sleep for 3 months

Other Name: BiPAP with Bi-Flex
Active Comparator: CPAP

Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.

Subjects in this arm received standard continuous positive airway pressure (CPAP) therapy.

In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea will randomized to CPAP or Bi-Flex, and repeat polysomnography will be performed on pressure at 3 months. Objective adherence data will be obtained at 1 and 3 months.

Device: CPAP

CPAP: Subjects in this arm undergo standard continuous positive airway pressure (CPAP) therapy.

Positive pressure used during sleep for 3 months.

Other Names:
  • CPAP
  • Continuous positive airway pressure

  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
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, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: January 10, 2013
Last Updated: March 31, 2014
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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014