Clinical trial NCT01138865: Effect of CPAP on Biomarkers in Patients With OSA
Official title: Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Cytokine levels
Insulin resistance
Hypertension
Dyslipidemia
Albumin-creatinine ratio
Continuous positive airway pressure (CPAP)
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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, mortality risks in the same patients.

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 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.

Eligibility criteria: Inclusion Criteria:

The 1st part of the study will include

1. males and females, aged 30-65 years,
2. with AHI \>5 and excessive daytime sleepiness
3. naïve to CPAP treatment.
4. 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:

1. Hypothyroidism
2. Chronic renal failure
3. Chronic liver disease
4. Chronic lung disease
5. Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
6. Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.)
7. Immune deficiency conditions
8. Pregnancy
9. Active menstruation at time of sampling
10. Macroalbuminuria (aACR\>300mg/g),
11. Patients of coronary artery disease and left ventricular dysfunction
12. Not on treatment for hypertension, diabetes mellitus or dyslipidemia
13. Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)

Primary outcomes:
measure: Effect of CPAP therapy on blood pressure
timeFrame: 7 months
measure: Effect of CPAP therapy on insulin resistance
timeFrame: 7months
measure: Effect of CPAP therapy on plasma hs-CRP
timeFrame: 7months
measure: Effect of CPAP therapy on lipid profile
timeFrame: 7months
measure: Effect of CPAP therapy on urinary albumin-creatinine ratio
timeFrame: 7months
Secondary outcomes:
measure: Effect of CPAP on anthropometric parameters
timeFrame: 3 months
measure: Effect of CPAP on visceral fat and other imagings
timeFrame: 3months
measure: Effect of CPAP on carotid intima medical thickness
timeFrame: 3months
measure: Effect of CPAP on adipokines and oxidative stress markers
timeFrame: 3months
measure: Effect of CPAP on inflammatory cytokine levels.
timeFrame: 3months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Surendra K Sharma, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: