Effect of CPAP on Biomarkers in Patients With OSA

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit
* Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The 1st part of the study will include males and females, aged 30-65 years, with AHI >5 and excessive daytime sleepiness naïve to CPAP treatment. Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension Exclusion Criteria: Hypothyroidism Chronic renal failure Chronic liver disease Chronic lung disease Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders), Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.) Immune deficiency conditions Pregnancy Active menstruation at time of sampling Macroalbuminuria (aACR>300mg/g), Patients of coronary artery disease and left ventricular dysfunction Not on treatment for hypertension, diabetes mellitus or dyslipidemia Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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 | Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit<br>* 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<br>* Other names: AutoSet Spirit(TM), ResMed India Ltd.;|
| Other: 2<br>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<br>* 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<br>* Other names: Modified-AutoSet Spirit(TM), ResMed India Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 3months | 
| Effect of CPAP on adipokines and oxidative stress markers |  | 3months | 
| Effect of CPAP on inflammatory cytokine levels. |  | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Cytokine levels, Insulin resistance, Hypertension, Dyslipidemia, Albumin-creatinine ratio, Continuous positive airway pressure (CPAP)