Differential Effects of Chronic Treatment of OSAS by CPAP and SOMNOsmart2 on Norepinephrine and Blood Pressure
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Blood pressure and urinary catecholamines after conventional or auto-CPAP
Study Overview
Brief Summary
The main purpose of this study is to investigate if treatment of obstructive sleep apnea syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP device administering a fixed air pressure, or by one automatic CPAP device ("Somnosmart2", Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite normetanephrine) and on blood pressure.
Detailed Description
A nocturnal home cardiorespiratory recording will performed for diagnosis of OSA. During the same night, patients will be asked to collect their urines. Twentyfour-hour ambulatory BP monitoring (ABPM) will be performed starting from the next morning. After analysis of the polygraphic recording, subjects with AHI <15 will be excluded from the study, while CPAP will be proposed as a treatment to the other patients.
Before starting treatment, a full night standard polysomnography will be performed: in subjects assigned to fixed CPAP for attended CPAP titration; in the other subjects during application of the Somnosmart2 device, to verify if obstructive events are adequately eliminated by it.
After analysis of polysomnography, patients will be given a fixed CPAP or the auto-CPAP device for nocturnal home use. Two months later, compliance to treatment will be verified measured by the in-built time counter of the devices. Then, cardiorespiratory monitoring during application of the device used for treatment, nocturnal urine collection and 24-hour ABPM will be repeated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Obstructive sleep apnea syndrome deserving CPAP treatment
Exclusion Criteria
- •current pharmacological treatment
Arms & Interventions
fixed CPAP
Intervention: fixed continuous positive airway pressure (CPAP) (Device)
Auto-CPAP
Auto-CPAP Weinmann "Somnosmart2"
Intervention: Automatic (variable, automatically controlled) pressure CPAP (Device)
Outcomes
Primary Outcomes
Blood pressure and urinary catecholamines after conventional or auto-CPAP
Time Frame: 2 months
Secondary Outcomes
- Relationship between catecholamines / blood pressure changes and compliance to treatment(2 months)