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
  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 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

  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
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:
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 August 28, 2014