Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Cytokine levels, Insulin resistance, Hypertension, Dyslipidemia, Albumin-creatinine ratio, Continuous positive airway pressure (CPAP)
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.
Interventions
DEVICEAutoSet 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
DEVICEModified-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
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of CPAP therapy on urinary albumin-creatinine ratio | 7months |
| 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 |
Secondary
| 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 |
Countries
India
Contacts
Primary ContactSurendra K Sharma, MD, Ph.D
Outcome results
None listed