Condition category
Nervous System Diseases
Date applied
20/02/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ingo Fietze

ORCID ID

Contact details

Charité - Universitätsmedizin Berlin
Charitéplatz 1
Berlin
10117
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/20-02-2008

Study information

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

Acronym

CPAP and hypertension

Study hypothesis

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

Charite - Universitaetsmedizin Berlin Ethics Committee gave approval on the 20th May 2008 (ref: EA1/044-08)

Study design

Prospective randomised interventional clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

23/02/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

23/02/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Charité - Universitätsmedizin Berlin
Berlin
10117
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

c/o Ingo Fietze
Charitéplatz 1
Berlin
10117
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/

Funders

Funder type

Industry

Funder name

Respironics, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes