Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea (OSA) and Effect of Treatment With Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome
Primary Purpose
Obstructive Sleep Apnea, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
AutoSet Spirit
Modified-AutoSet Spirit
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Metabolic syndrome, Insulin resistance, Hypertension, Dyslipidemia, Continuous positive airway pressure (CPAP)
Eligibility 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
- Proliferative diabetic retinopathy
- Nephropathy (serum creatinine >1.8 mg/dL)
- Clinically manifest neuropathy defined as absent ankle jerks.
- Severe hyperglycemia (FBS >200 mg/dL)
Hypertensive subjects will be excluded if any one of the following is present
- Symptomatic coronary artery disease
- Symptomatic peripheral vascular disease
- Past history of cerebrovascular accident
- Known case of aortic aneurysm or left ventricular dysfunction
- Nephropathy (serum creatinine >1.8 mg/dL)
- Marked elevation in blood pressure (BP >180/110 mm Hg on two occasions)
Sites / Locations
- All India Institute of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
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
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
Outcomes
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
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)
Full Information
NCT ID
NCT00694616
First Posted
June 5, 2008
Last Updated
June 22, 2013
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT00694616
Brief Title
Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea (OSA) and Effect of Treatment With Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Metabolic Syndrome
Keywords
Obstructive sleep apnea, Metabolic syndrome, Insulin resistance, Hypertension, Dyslipidemia, Continuous positive airway pressure (CPAP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
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
Arm Title
2
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
AutoSet Spirit
Other Intervention Name(s)
AutoSet Spirit(TM), ResMed India Ltd.
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Modified-AutoSet Spirit
Other Intervention Name(s)
Modified-AutoSet Spirit(TM), ResMed India Ltd.
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Proliferative diabetic retinopathy
Nephropathy (serum creatinine >1.8 mg/dL)
Clinically manifest neuropathy defined as absent ankle jerks.
Severe hyperglycemia (FBS >200 mg/dL)
Hypertensive subjects will be excluded if any one of the following is present
Symptomatic coronary artery disease
Symptomatic peripheral vascular disease
Past history of cerebrovascular accident
Known case of aortic aneurysm or left ventricular dysfunction
Nephropathy (serum creatinine >1.8 mg/dL)
Marked elevation in blood pressure (BP >180/110 mm Hg on two occasions)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra K Sharma, M.D., Ph.D.
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110608
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
22168642
Citation
Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. CPAP for the metabolic syndrome in patients with obstructive sleep apnea. N Engl J Med. 2011 Dec 15;365(24):2277-86. doi: 10.1056/NEJMoa1103944.
Results Reference
derived
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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
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