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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
AutoSet Spirit--Wash--Modified-AutoSet Spirit
Modified-AutoSet Spirit--Wash-AutoSet Spirit
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Cytokine levels, Insulin resistance, Hypertension, Dyslipidemia, Albumin-creatinine ratio, Continuous positive airway pressure (CPAP)

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • All India Institute of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effect of CPAP therapy on blood pressure
Effect of CPAP therapy on insulin resistance
Effect of CPAP therapy on plasma hs-CRP
Effect of CPAP therapy on lipid profile
Effect of CPAP therapy on urinary albumin-creatinine ratio

Secondary Outcome Measures

Effect of CPAP on anthropometric parameters
Effect of CPAP on visceral fat and other imagings
Effect of CPAP on carotid intima medical thickness
Effect of CPAP on adipokines and oxidative stress markers
Effect of CPAP on inflammatory cytokine levels.

Full Information

First Posted
June 2, 2010
Last Updated
June 21, 2013
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01138865
Brief Title
Effect of CPAP on Biomarkers in Patients With OSA
Acronym
CPAP
Official Title
Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Cytokine levels, Insulin resistance, Hypertension, Dyslipidemia, Albumin-creatinine ratio, Continuous positive airway pressure (CPAP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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
Arm Title
2
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
AutoSet Spirit--Wash--Modified-AutoSet Spirit
Other Intervention Name(s)
AutoSet Spirit(TM), ResMed India Ltd.
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Modified-AutoSet Spirit--Wash-AutoSet Spirit
Other Intervention Name(s)
Modified-AutoSet Spirit(TM), ResMed India Ltd.
Intervention Description
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
Primary Outcome Measure Information:
Title
Effect of CPAP therapy on blood pressure
Time Frame
7 months
Title
Effect of CPAP therapy on insulin resistance
Time Frame
7months
Title
Effect of CPAP therapy on plasma hs-CRP
Time Frame
7months
Title
Effect of CPAP therapy on lipid profile
Time Frame
7months
Title
Effect of CPAP therapy on urinary albumin-creatinine ratio
Time Frame
7months
Secondary Outcome Measure Information:
Title
Effect of CPAP on anthropometric parameters
Time Frame
3 months
Title
Effect of CPAP on visceral fat and other imagings
Time Frame
3months
Title
Effect of CPAP on carotid intima medical thickness
Time Frame
3months
Title
Effect of CPAP on adipokines and oxidative stress markers
Time Frame
3months
Title
Effect of CPAP on inflammatory cytokine levels.
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Surendra K Sharma, MD, Ph.D
Phone
91-11-26594415
Email
sksharma@aiims.ac.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra K Sharma, MD,Ph.D
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surendra K Sharma, MD, Ph.D
Phone
91-11-26594415
Email
sksharma@aiims.ac.in
First Name & Middle Initial & Last Name & Degree
Surender K Sharma, MD, Ph.D
First Name & Middle Initial & Last Name & Degree
M Irshad, MD
First Name & Middle Initial & Last Name & Degree
Vishubhatla Sreenivas, Ph.D
First Name & Middle Initial & Last Name & Degree
Ramakrishnan Lakshmy, Ph.D
First Name & Middle Initial & Last Name & Degree
Manish Soneja, MD
First Name & Middle Initial & Last Name & Degree
Atin Kumar, MD
First Name & Middle Initial & Last Name & Degree
Priya Jagia, MD
First Name & Middle Initial & Last Name & Degree
Deepak Damodaran, M.B.B.S.

12. IPD Sharing Statement

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Effect of CPAP on Biomarkers in Patients With OSA

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