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

Sponsored by:	Laval University
Information provided by:	Laval University
ClinicalTrials.gov Identifier:	NCT00729963

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 IV

MedlinePlus related topics: High Blood Pressure Obesity Sleep Apnea Weight Control

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Efficacy of Sibutramine-Induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea

Further study details as provided by Laval University:

Enrollment:

45

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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

No Contacts or Locations Provided

More Information

Responsible Party:	Laval Hospital ( Frédéric Sériès )
Study ID Numbers:	CER911
Study First Received:	August 6, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00729963
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Obesity
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Vascular Diseases
Dyssomnias
Sleep Disorders
Overweight
Sleep Disorders, Intrinsic

Sibutramine
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Weight Loss
Nutrition Disorders
Signs and Symptoms, Respiratory
Overnutrition
Hypertension

Additional relevant MeSH terms:

Anti-Obesity Agents
Therapeutic Uses
Nervous System Diseases
Psychotropic Drugs
Appetite Depressants

Cardiovascular Diseases
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009