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CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.
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. It is a highly prevalent though under-recognized clinical problem.There is increasing evidence that inflammation plays important role in development of cardiovascular complications in patients with OSA.
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 cardiovascular biomarkers in people with OSAS has not been satisfactorily assessed.
This study aims to assess the effect of CPAP treatment on cardiovascular biomarkers in OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | 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 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoSet Spirit--Wash--Modified-AutoSet Spirit | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of CPAP therapy on blood pressure | 7 months | |
| Effect of CPAP therapy on insulin resistance | 7months | |
| Effect of CPAP therapy on plasma hs-CRP | 7months | |
| Effect of CPAP therapy on lipid profile | 7months | |
| Effect of CPAP therapy on urinary albumin-creatinine ratio | 7months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of CPAP on anthropometric parameters | 3 months | |
| Effect of CPAP on visceral fat and other imagings | 3months | |
| Effect of CPAP on carotid intima medical thickness |
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Inclusion Criteria:
The 1st part of the study will include
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Surendra K Sharma, MD, Ph.D | Contact | 91-11-26594415 | sksharma@aiims.ac.in |
| Name | Affiliation | Role |
|---|---|---|
| Surendra K Sharma, MD,Ph.D | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007333 | Insulin Resistance |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Modified-AutoSet Spirit--Wash-AutoSet Spirit | Device | 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 |
|
|
| 3months |
| Effect of CPAP on adipokines and oxidative stress markers | 3months |
| Effect of CPAP on inflammatory cytokine levels. | 3months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |