Effect of CPAP on Biomarkers in Patients With OSA

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2013 by All India Institute of Medical Sciences, New Delhi

Sponsor:

Information provided by (Responsible Party):

S.K.SHARMA, All India Institute of Medical Sciences, New Delhi

ClinicalTrials.gov Identifier:

NCT01138865

First received: June 2, 2010

Last updated: June 21, 2013

Last verified: June 2013

History of Changes

Purpose

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	Intervention	Phase
Obstructive Sleep Apnea	Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Sleep Apnea

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Effect of CPAP therapy on blood pressure [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Effect of CPAP therapy on insulin resistance [ Time Frame: 7months ] [ Designated as safety issue: No ]
Effect of CPAP therapy on plasma hs-CRP [ Time Frame: 7months ] [ Designated as safety issue: No ]
Effect of CPAP therapy on lipid profile [ Time Frame: 7months ] [ Designated as safety issue: No ]
Effect of CPAP therapy on urinary albumin-creatinine ratio [ Time Frame: 7months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of CPAP on anthropometric parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Effect of CPAP on visceral fat and other imagings [ Time Frame: 3months ] [ Designated as safety issue: No ]
Effect of CPAP on carotid intima medical thickness [ Time Frame: 3months ] [ Designated as safety issue: No ]
Effect of CPAP on adipokines and oxidative stress markers [ Time Frame: 3months ] [ Designated as safety issue: No ]
Effect of CPAP on inflammatory cytokine levels. [ Time Frame: 3months ] [ Designated as safety issue: No ]


Estimated Enrollment:	100
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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


Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138865

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

No publications provided


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
Study First Received:	June 2, 2010
Last Updated:	June 21, 2013
Health Authority:	India: Department of Biotechnology

Keywords provided by 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:


Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders	Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on March 03, 2015

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