Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients
Efficacy of Sibutramine-induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The primary objective of this study is to observe if Sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to document the effects of Sibutramine on heart rate variability and 24-h arterial pressure values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (OSA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2004
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 6, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedApril 11, 2013
April 1, 2013
3.7 years
August 6, 2008
April 9, 2013
Conditions
Study Arms (2)
1
EXPERIMENTALThe first group received sibutramine 10 mg for the first 4 weeks, at which time consideration of increasing dosage to 15 mg was re-evaluated in the case of insufficient weight loss (\< 1.8 kg) over the first month of treatment.
2
ACTIVE COMPARATORA standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA.
Interventions
The first group received sibutramine 10 mg for the first 4 weeks, at which time consideration of increasing dosage to 15 mg was re-evaluated in the case of insufficient weight loss (\< 1.8 kg) over the first month of treatment.
Eligibility Criteria
You may qualify if:
- Eligible participants with non-treated OSA syndrome were aged between 18 to 65 years, with a body-mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 in the presence of other risk factors such as controlled systemic hypertension, type 2 diabetes, dyslipidemia and/or visceral obesity (as defined by a waist circumference ≥ 102 cm in men and ≥ 88 cm in women).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Related Publications (1)
Ferland A, Poirier P, Series F. Sibutramine versus continuous positive airway pressure in obese obstructive sleep apnoea patients. Eur Respir J. 2009 Sep;34(3):694-701. doi: 10.1183/09031936.00167308. Epub 2009 Apr 8.
PMID: 19357147DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 6, 2008
First Posted
August 8, 2008
Study Start
January 1, 2004
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
April 11, 2013
Record last verified: 2013-04