Status:

COMPLETED

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

Lead Sponsor:

Laval University

Conditions:

Obstructive Sleep Apnea

Obesity

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2007

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00729963

Start Date

January 1 2004

End Date

September 1 2007

Last Update

April 11 2013

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