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Sponsored by: |
All India Institute of Medical Sciences, New Delhi |
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Information provided by: | All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT00694616 |
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 |
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Obstructive Sleep Apnea Metabolic Syndrome |
Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 53 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated 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--Wash--Modified-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
|
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--Wash-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
|
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.
Ages Eligible for Study: | 30 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Diabetic subjects will be excluded if any one of the following is present
Hypertensive subjects will be excluded if any one of the following is present
Contact: Surendra K Sharma, M.D., Ph.D. | 26-594-415 | surensk@gmail.com |
India | |
All India Institute of Medical Sciences | Recruiting |
New Delhi, India, 110608 | |
Contact: Surendra K Sharma, M.D., Ph.D. 26-594-415 surensk@gmail.com | |
Principal Investigator: Surendra K Sharma, M.D., Ph.D. | |
Sub-Investigator: Ramakrishnan Lakshmy, Ph.D. | |
Sub-Investigator: Atin Kumar, M.D. | |
Sub-Investigator: Tamilarasu Kadhiravan, M.D. |
Principal Investigator: | Surendra K Sharma, M.D., Ph.D. | All India Institute of Medical Sciences, New Delhi |
Responsible Party: | All India Institute of Medical Sciences ( Professor S.K. Sharma, Head, Department of Medicine ) |
Study ID Numbers: | SKS/OSA/CPAP/2008 |
Study First Received: | June 5, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00694616 |
Health Authority: | India: Institutional Review Board |
Obstructive sleep apnea Metabolic syndrome Insulin resistance |
Hypertension Dyslipidemia Continuous positive airway pressure (CPAP) |
Sleep Apnea Syndromes Apnea Sleep Apnea, Obstructive Respiration Disorders Sleep Disorders Dyssomnias Insulin |
Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Insulin Resistance Dyslipidemias Hypertension |
Pathologic Processes Disease Syndrome Nervous System Diseases |