Effect of CPAP on Biomarkers in Patients With OSA

All India Institute Of Medical Science (AIIMS)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit; Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit

Study type: Interventional

Funder types: Other

Identifiers

NCT01138865

SKS/CPAP-OSAS/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Other group

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

Treatment:

Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit

2

Other group

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

Treatment:

Device: Modified-AutoSet Spirit--Wash-AutoSet Spirit