Effect of CPAP on Biomarkers in Patients With OSA (CPAP)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit; Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
Study Start Date :	March 2012
Estimated Primary Completion Date :	September 2014
Estimated Study Completion Date :	March 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
1; 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; 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; Other Name: AutoSet Spirit(TM), ResMed India Ltd.
2; 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; 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; Other Name: Modified-AutoSet Spirit(TM), ResMed India Ltd.

Outcome Measures

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Primary Outcome Measures :

1. Effect of CPAP therapy on blood pressure [ Time Frame: 7 months ]
2. Effect of CPAP therapy on insulin resistance [ Time Frame: 7months ]
3. Effect of CPAP therapy on plasma hs-CRP [ Time Frame: 7months ]
4. Effect of CPAP therapy on lipid profile [ Time Frame: 7months ]
5. Effect of CPAP therapy on urinary albumin-creatinine ratio [ Time Frame: 7months ]

Secondary Outcome Measures :

1. Effect of CPAP on anthropometric parameters [ Time Frame: 3 months ]
2. Effect of CPAP on visceral fat and other imagings [ Time Frame: 3months ]
3. Effect of CPAP on carotid intima medical thickness [ Time Frame: 3months ]
4. Effect of CPAP on adipokines and oxidative stress markers [ Time Frame: 3months ]
5. Effect of CPAP on inflammatory cytokine levels. [ Time Frame: 3months ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Surendra K Sharma, MD, Ph.D	91-11-26594415	sksharma@aiims.ac.in

Locations

India
All India Institute of Medical Sciences	Recruiting
New Delhi, Delhi, India, 110029
Contact: Surendra K Sharma, MD, Ph.D 91-11-26594415 sksharma@aiims.ac.in
Principal Investigator: Surender K Sharma, MD, Ph.D
Sub-Investigator: M Irshad, MD
Sub-Investigator: Vishubhatla Sreenivas, Ph.D
Sub-Investigator: Ramakrishnan Lakshmy, Ph.D
Sub-Investigator: Manish Soneja, MD
Sub-Investigator: Atin Kumar, MD
Sub-Investigator: Priya Jagia, MD
Sub-Investigator: Deepak Damodaran, M.B.B.S.

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

Principal Investigator:	Surendra K Sharma, MD,Ph.D	All India Institute of Medical Sciences, New Delhi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	S.K.SHARMA, Professor and Haed, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT01138865 History of Changes
Other Study ID Numbers:	SKS/CPAP-OSAS/2009
First Posted:	June 8, 2010
Last Update Posted:	June 24, 2013
Last Verified:	June 2013

Keywords provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:

Obstructive sleep apnea; Cytokine levels; Insulin resistance; Hypertension	Dyslipidemia; Albumin-creatinine ratio; Continuous positive airway pressure (CPAP)

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory	Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases