Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea (OSA)
This study is ongoing, but not recruiting participants.
Sponsor:
All India Institute of Medical Sciences, New Delhi
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: July 24, 2012
Last verified: July 2012
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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:
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 [ 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 plasma leptin [ 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: | 90 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (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>250),
- patients of coronary artery disease and left ventricular dysfunction
- Diabetes mellitus(FBS >126 mg/dL or HbA1c >6.5g/dL or On treatment for diabetes mellitus)
- Hypertension (systolic BP>140mm Hg or diastolic BP>90mm Hg or on treatment for hypertension)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138865
Locations
| India | |
| All India Institute of Medical Sciences | |
| New Delhi, Delhi, India, 110029 | |
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: | July 24, 2012 |
| Health Authority: | India: Ministry of Health |
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:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013