Impact of standard continous positive airway pressure (CPAP) therapy on arterial hypertension in patients with obstructive sleep apnoea syndrome (OSAS)
| ISRCTN | ISRCTN42722501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42722501 |
| Secondary identifying numbers | 01/20-02-2008 |
- Submission date
- 20/02/2009
- Registration date
- 20/04/2009
- Last edited
- 20/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ingo Fietze
Scientific
Scientific
Charité - Universitätsmedizin Berlin
Charitéplatz 1
Berlin
10117
Germany
Study information
| Study design | Prospective randomised interventional clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of standard continous positive airway pressure (CPAP) therapy on arterial hypertension in patients with obstructive sleep apnoea syndrome (OSAS): a prospective randomised interventional clinical trial |
| Study acronym | CPAP and hypertension |
| Study objectives | The purpose of this study is to provide evidence for the impact of non-invasive positive airway pressure ventilation therapy (CPAP) on recently diagnosed and still untreated hypertension. A comparison of the 24-hour ambulatory blood pressure monitoring results of group A (subjects with obstructive sleep apnoea [OSA] and hypertension) before and 3 months after adjustment to CPAP-therapy. Simultaneously we will examine the 24-hour blood pressure results of a control group B (subjects with OSA and hypertension) which will not receive CPAP nor hypertension treatment over a period of 3 months (natural course). Diagnostics of blood pressure will be performed by 24-hour ambulatory blood pressure monitoring, sleep apnoea diagnostics will be conducted by night attended cardiorespiratory polysomnography (PSG) in the sleep lab. Adjustment to nocturnal ventilation therapy (CPAP) will also take place in sleep lab as well as the control study with (group A) and without (group B) CPAP after the 3-month period. During the first night in sleep lab (diagnostics) as well as during the control night after 3 months an additional recording of peripheral arterial tonometry (PAT) on the fingertip will be performed. |
| Ethics approval(s) | Charite - Universitaetsmedizin Berlin Ethics Committee gave approval on the 20th May 2008 (ref: EA1/044-08) |
| Health condition(s) or problem(s) studied | Obstructive sleep apnoea |
| Intervention | Prospective randomised interventional clinical trial including 40 patients with an OSAS which requires treatment and with recently diagnosed arterial hypertension. Group A: patients receive CPAP treatment immediately Group B: patients start CPAP treatment 3 months later Routines: 1. 24-hour ambulatory blood pressure (ABP) monitoring 2. Night attended polysomnography with additional PAT on fingertip 3. Night attended polysomnography with CPAP titration (1 APAP plus 1 CPAP night) 4. Home treatment with individual CPAP-mode 5. After 3 months repetition of night attended polysomnography with additional PAT on fingertip 6. Electrocardiogram (ECG) (12-lead) 7. Pulmonary function test (spirometry) 8. Ambulatory cardiorespiratory polygraphy 9. 24-hour ambulatory blood pressure (ABP) monitoring 10. Checking for inclusion/exclusion criteria 11. Sonography of kidney arteries 12. Vanillylmandelic acid (VMA) in urine Total duration of treatment: 12 weeks Total duration of follow-up: 12 weeks |
| Intervention type | Other |
| Primary outcome measure | Arterial blood pressure with and without CPAP-therapy over the course of 3 months |
| Secondary outcome measures | 1. Cardiac output (left ventricular ejection fraction [LVEF]) 2. Nocturnal PAT 3. Quality of sleep 4. Quality of life (QoL) 5. Day sleepiness (Epworth Sleepiness Scale [ESS] score) Measured before randomisation, first therapy night (day one of the study), and after 12 weeks. |
| Overall study start date | 23/02/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 23/02/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - Universitätsmedizin Berlin
Berlin
10117
Germany
10117
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Ingo Fietze
Charitéplatz 1
Berlin
10117
Germany
| Website | http://www.charite.de/ |
|---|---|
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Industry
Respironics, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
