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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694616
• Other study ID #: SKS/OSA/CPAP/2008
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: June 22, 2013
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2013
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Metabolic Syndrome
• Metabolic Syndrome X
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects satisfying the National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP III) criteria for the diagnosis of metabolic syndrome		3 months	No
Secondary	Individual components of the NCEP-ATP III criteria (FBS, BP, LDL cholesterol, HDL cholesterol, triglycerides) and insulin resistance (assessed by HOMA-IR)		3 months	No