Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients - Full Text View

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:

MedlinePlus related topics: Sleep Apnea Weight Control

U.S. FDA Resources

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 (Adult)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1183/09031936.00167308. Epub 2009 Apr 8.


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:


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

ClinicalTrials.gov processed this record on September 29, 2016