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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Laval University:

Enrollment: 45
Study Start Date: January 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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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No Contacts or Locations Provided
  More Information

No publications provided by Laval University

Additional 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
Study First Received: August 6, 2008
Last Updated: April 9, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hypertension
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents

ClinicalTrials.gov processed this record on September 22, 2014