Status:
UNKNOWN
Effect of CPAP on Biomarkers in Patients With OSA
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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, m...
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 repea...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01138865
Start Date
March 1 2012
End Date
March 1 2015
Last Update
June 24 2013
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029