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Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients
This study has been completed.
Sponsor:
Laval University
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00729963
First received: August 6, 2008
Last updated: April 9, 2013
Last verified: April 2013
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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 (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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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 |
| Study First Received: | August 6, 2008 |
| Last Updated: | April 9, 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 |
ClinicalTrials.gov processed this record on July 19, 2017