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Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea (OSA) and Effect of Treatment With Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00694616
First received: June 5, 2008
Last updated: April 6, 2011
Last verified: April 2011
History of Changes
  Purpose

Metabolic syndrome is a constellation of risk factors for cardiovascular disease. The prevalence of metabolic syndrome in persons with obstructive sleep apnea syndrome (OSAS) is known to be very high, about 70%. However, it is unclear whether this association is causal or not. Results of earlier studies have been conflicting. The investigators hypothesize that treatment with auto-titrating continuous positive airway pressure (auto-CPAP) for a duration of 3 months improves the metabolic syndrome in subjects with OSAS.


Condition Intervention
Obstructive Sleep Apnea
Metabolic Syndrome
 Device: AutoSet Spirit
Device: Modified-AutoSet Spirit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea and the Effect of Treatment With Auto-titrating Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Proportion of subjects satisfying the National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP III) criteria for the diagnosis of metabolic syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual components of the NCEP-ATP III criteria (FBS, BP, LDL cholesterol, HDL cholesterol, triglycerides) and insulin resistance (assessed by HOMA-IR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
 Device: AutoSet Spirit
3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
Other Name: AutoSet Spirit(TM), ResMed India Ltd.
2
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
 Device: Modified-AutoSet Spirit
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
Other Name: Modified-AutoSet Spirit(TM), ResMed India Ltd.

Detailed Description:

Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. OSA is a highly prevalent though under-recognized clinical problem. The Wisconsin study estimated a prevalence of 24% in males and 9% in females. A population-based study in Delhi, India found the prevalence of OSA to be 13.7% and that of obstructive sleep apnea syndrome (OSAS) to be 3.8%.

OSA is associated with various systemic complications such as neurocognitive dysfunction, cardiovascular disease, insulin resistance, and dyslipidemia. There is an increased risk of motor vehicle and occupational accidents in people suffering from OSAS.

Metabolic syndrome is the co-occurrence of several cardiovascular risk factors such as abdominal obesity, hypertension, impaired glucose tolerance and dyslipidemia. Presence of OSA together with metabolic syndrome is known as 'Syndrome Z'. Although many studies have shown that OSA is associated with metabolic syndrome, the exact causal relationship between these two entities is not proven.

Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms. However, it is a costly treatment option, and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on metabolic syndrome in people with OSAS is unclear.

This study aims to assess the effect of CPAP treatment on metabolic syndrome in patients with OSAS.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with moderately severe OSAS (AHI >= 15 with excessive daytime sleepiness) also having metabolic syndrome, and have never received treatment for OSAS, diabetes mellitus and hypertension

Exclusion Criteria:

  • Diabetic subjects will be excluded if any one of the following is present

    1. Proliferative diabetic retinopathy
    2. Nephropathy (serum creatinine >1.8 mg/dL)
    3. Clinically manifest neuropathy defined as absent ankle jerks.
    4. Severe hyperglycemia (FBS >200 mg/dL)

  • Hypertensive subjects will be excluded if any one of the following is present

    1. Symptomatic coronary artery disease
    2. Symptomatic peripheral vascular disease
    3. Past history of cerebrovascular accident
    4. Known case of aortic aneurysm or left ventricular dysfunction
    5. Nephropathy (serum creatinine >1.8 mg/dL)
    6. Marked elevation in blood pressure (BP >180/110 mm Hg on two occasions)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694616

Locations
India
All India Institute of Medical Sciences
New Delhi, India, 110608
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Surendra K Sharma, M.D., Ph.D. All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor S.K. Sharma, Head, Department of Medicine, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00694616     History of Changes
Other Study ID Numbers: SKS/OSA/CPAP/2008
Study First Received: June 5, 2008
Last Updated: April 6, 2011
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Obstructive sleep apnea
Metabolic syndrome
Insulin resistance
 Hypertension
Dyslipidemia
Continuous positive airway pressure (CPAP)

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Metabolic Syndrome X
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013