Status:
COMPLETED
Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Philips Respironics
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief Summary
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 treat...
Detailed Description
STUDY RATIONALE The obstructive sleep apnea syndrome (OSAS) affects approximately 2% of children and results in significant morbidity. Continuous positive airway pressure (CPAP) is the standard therap...
Eligibility Criteria
Inclusion
- Males or females aged 2 to 16 years.
- OSAS diagnosed on polysomnography.
- Positive airway pressure therapy indicated by patient's physician because surgery was either contraindicated or ineffective.
- No plans for upper airway surgery in the next 3 months.
Exclusion
- 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.
- Age greater or equal to 16 years, as results may be similar to adult studies in these older patients.
- Previous use of CPAP / bilevel ventilation.
- Unable to read / understand English. -
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00458406
Start Date
May 1 2007
End Date
April 1 2012
Last Update
October 2 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19103