Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients
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ClinicalTrials.gov Identifier: NCT00729963 |
Recruitment Status
:
Completed
First Posted
: August 8, 2008
Last Update Posted
: April 11, 2013
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Sponsor:
Laval University
Information provided by:
Laval University
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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).
Condition or disease | Intervention/treatment | Phase |
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Obstructive Sleep Apnea Obesity Hypertension | Drug: Sibutramine Device: CPAP | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Sibutramine-induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Obstructive sleep apnea
U.S. FDA Resources
Arm | Intervention/treatment |
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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.
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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.
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Active Comparator: 2
A standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA.
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Device: CPAP |
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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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.
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Frédéric Sériès, Laval Hospital |
ClinicalTrials.gov Identifier: | NCT00729963 History of Changes |
Other Study ID Numbers: |
CER911 |
First Posted: | August 8, 2008 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | April 2013 |
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 Wake Disorders Nervous System Diseases Sibutramine Antidepressive Agents Psychotropic Drugs Appetite Depressants Anti-Obesity Agents |