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

Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit; Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110029
      • Recruiting
      • All India Institute of Medical Sciences
      • Sub-Investigator: Manish Soneja, MD
      • Contact: Surendra K Sharma, MD, Ph.D; Phone Number: 91-11-26594415; Email: 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: Atin Kumar, MD
      • Sub-Investigator: Priya Jagia, MD
      • Sub-Investigator: Deepak Damodaran, M.B.B.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: AutoSet Spirit(TM), ResMed India Ltd.
Other: 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 Names: Modified-AutoSet Spirit(TM), ResMed India Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of CPAP therapy on blood pressure	7 months
Effect of CPAP therapy on insulin resistance	7months
Effect of CPAP therapy on plasma hs-CRP	7months
Effect of CPAP therapy on lipid profile	7months
Effect of CPAP therapy on urinary albumin-creatinine ratio	7months

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of CPAP on anthropometric parameters	3 months
Effect of CPAP on visceral fat and other imagings	3months
Effect of CPAP on carotid intima medical thickness	3months
Effect of CPAP on adipokines and oxidative stress markers	3months
Effect of CPAP on inflammatory cytokine levels.	3months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (Estimate): June 8, 2010

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Insulin resistance; Dyslipidemia; Hypertension; Obstructive sleep apnea; Continuous positive airway pressure (CPAP); Cytokine levels; Albumin-creatinine ratio
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: SKS/CPAP-OSAS/2009