Impact of standard continous positive airway pressure (CPAP) therapy on arterial hypertension in patients with obstructive sleep apnoea syndrome (OSAS)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42722501

Enrollment

Registered

2009-04-20

Start date

2009-02-23

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnoea Nervous System Diseases Sleep disorders

Interventions

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 treat

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Arterial blood pressure with and without CPAP-therapy over the course of 3 months	—

Secondary

Measure	Time frame
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.	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026