search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea, Obesity, Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sibutramine
CPAP
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    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.

    A standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2008
    Last Updated
    April 9, 2013
    Sponsor
    Laval University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00729963
    Brief Title
    Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients
    Official Title
    Efficacy of Sibutramine-induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laval University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea, Obesity, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    A standard reference group, which was paired according to age and BMI, received CPAP as a treatment for OSA.
    Intervention Type
    Drug
    Intervention Name(s)
    Sibutramine
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    CPAP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19357147
    Citation
    Ferland A, Poirier P, Series 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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs