Effect of CPAP on Biomarkers in Patients With OSA

Obstructive Sleep Apnea Clinical Trial

— CPAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01138865
• Other study ID #: SKS/CPAP-OSAS/2009
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 2, 2010
• Last updated: June 21, 2013
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2013
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Surendra K Sharma, MD, Ph.D
• Phone: 91-11-26594415
• Email: sksharma[@]aiims.ac.in
• Is FDA regulated: No
• Health authority: India: Department of Biotechnology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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
• 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

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of CPAP therapy on blood pressure		7 months	No
Primary	Effect of CPAP therapy on insulin resistance		7months	No
Primary	Effect of CPAP therapy on plasma hs-CRP		7months	No
Primary	Effect of CPAP therapy on lipid profile		7months	No
Primary	Effect of CPAP therapy on urinary albumin-creatinine ratio		7months	No
Secondary	Effect of CPAP on anthropometric parameters		3 months	No
Secondary	Effect of CPAP on visceral fat and other imagings		3months	No
Secondary	Effect of CPAP on carotid intima medical thickness		3months	No
Secondary	Effect of CPAP on adipokines and oxidative stress markers		3months	No
Secondary	Effect of CPAP on inflammatory cytokine levels.		3months	No