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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
Sponsor:
Information provided by:
Laval University

Study Description
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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
Obstructive Sleep Apnea Obesity Hypertension Drug: Sibutramine Device: CPAP Phase 4

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Active Comparator: 2
A standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA.
 Device: CPAP


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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