Overview

Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients

Status:
Completed

Trial end date:
2007-09-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Laval University

Treatments:

Sibutramine

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.