Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

This study has been completed.
Sponsor:
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00729963
First received: August 6, 2008
Last updated: April 9, 2013
Last verified: April 2013

August 6, 2008
April 9, 2013
January 2004
September 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00729963 on ClinicalTrials.gov Archive Site
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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

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).

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Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Obesity
  • Hypertension
  • Drug: Sibutramine
    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.
  • Device: CPAP
  • Experimental: 1
    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.
    Intervention: Drug: Sibutramine
  • Active Comparator: 2
    A standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA.
    Intervention: Device: CPAP
Ferland A, Poirier P, Sériès F. Sibutramine versus continuous positive airway pressure in obese obstructive sleep apnoea patients. Eur Respir J. 2009 Sep;34(3):694-701. Epub 2009 Apr 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Exclusion criteria were uncontrolled systemic hypertension defined as blood pressure > 145/90 mm Hg, previous pharmacological or surgical treatment for weight loss, had already used CPAP or had severe diurnal hyper somnolence requiring immediate treatment.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00729963
CER911
Yes
Frédéric Sériès, Laval Hospital
Laval University
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Laval University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP