Impact of standard continous positive airway pressure (CPAP) therapy on arterial hypertension in patients with obstructive sleep apnoea syndrome (OSAS)
- Conditions
- Obstructive sleep apnoeaNervous System DiseasesSleep disorders
- Registration Number
- ISRCTN42722501
- Lead Sponsor
- Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Apnoea Hypopnoea Index (AHI) greater than or equal to 15/h
2. Aged greater than 18 years, either sex
3. Patient's signature on informed consent after receiving oral and written information about the study
4. Levels of hypertension 1 - 3 and isolated sytolic hypertension
1. History with hypertentious crisis, known cardiac risks (coronary heart disease [CHD], heart failure, cardiac arrhythmia, congenital heart diseases)
2. Level 3 hypertension, unless patient refuses pharmacological treatment
3. Medication or drug abuse
4. Ongoing hypertension medication
5. Intake of any medication affecting sleep (e.g., medication affecting the central nervous system, tranquilisers)
6. Alcohol abuse with a daily consumption of greater than 30 g on a regularly basis
7. Participation in a pharmalogical clinical trial within 4 weeks prior to enrolment to this study
8. Normal blood pressure recordings in ambulatory blood pressure monitoring (ABPM)
9. Any psychiatric or neurological sickness which could influence sleep or therapy compliance
10. Dysfunction of thyroid gland
11. Chronic pain symptoms of any origin
12. Acute cardiac, pulmonary or other internal organ diseases
13. Chronic cardiac, pulmonary or other internal organ diseases that could influence sleep
14. Existing central sleep-related breathing disorder
15. Restless legs syndrome (RLS) and/or periodic leg movement sydrome (PLMS); (Periodic Limb Movement Index [PLMI] greater than 10/h)
16. Apoplex and/or myocardial infarction history
17. Diabetes mellitus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Arterial blood pressure with and without CPAP-therapy over the course of 3 months
- Secondary Outcome Measures
Name Time Method 1. Cardiac output (left ventricular ejection fraction [LVEF])<br>2. Nocturnal PAT<br>3. Quality of sleep<br>4. Quality of life (QoL)<br>5. Day sleepiness (Epworth Sleepiness Scale [ESS] score)<br><br>Measured before randomisation, first therapy night (day one of the study), and after 12 weeks.