Effect of CPAP on Biomarkers in Patients With OSA (CPAP)
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ClinicalTrials.gov Identifier: NCT01138865 |
Recruitment Status
: Unknown
Verified June 2013 by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Recruiting
First Posted
: June 8, 2010
Last Update Posted
: June 24, 2013
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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 |
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 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 |

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
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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.
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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.
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- Effect of CPAP therapy on blood pressure [ Time Frame: 7 months ]
- Effect of CPAP therapy on insulin resistance [ Time Frame: 7months ]
- Effect of CPAP therapy on plasma hs-CRP [ Time Frame: 7months ]
- Effect of CPAP therapy on lipid profile [ Time Frame: 7months ]
- Effect of CPAP therapy on urinary albumin-creatinine ratio [ Time Frame: 7months ]
- Effect of CPAP on anthropometric parameters [ Time Frame: 3 months ]
- Effect of CPAP on visceral fat and other imagings [ Time Frame: 3months ]
- Effect of CPAP on carotid intima medical thickness [ Time Frame: 3months ]
- Effect of CPAP on adipokines and oxidative stress markers [ Time Frame: 3months ]
- Effect of CPAP on inflammatory cytokine levels. [ Time Frame: 3months ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138865
Contact: Surendra K Sharma, MD, Ph.D | 91-11-26594415 | sksharma@aiims.ac.in |
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. |
Principal Investigator: | Surendra K Sharma, MD,Ph.D | All India Institute of Medical Sciences, New Delhi |
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 Key Record Dates |
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 |