Prospective cohort study on the effect of surgical treatment of obstructive sleep apnea syndrome on blood pressure (and other cardiovascular risk factors).
- Conditions
- obstructive sleep apnea syndromebloeddruksleep disordered breathing1004630410038737
- Registration Number
- NL-OMON30534
- Lead Sponsor
- Sint Lucas Andreas Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Epsworth Sleepiness Scale (ESS) >9
Apnea Hypopnea Index(AHI) * 15
Exclusion Criteria
Patients with an AHI<15 or ESS<10 or who suffer from predominant central sleep apnea or have contraindications for surgery will be excluded. Patients in whom relevant cardiovascular medication (lipid lowering drugs, ACE-/AT-1-inhibitors, ß-blocking agents, diuretics, calcium antagonists, nitrates, oral anti-diabetics and insulin therapy) is altered or started during follow-up will be excluded. Patients in whom OSAS surgery was not successful will be excluded. Patients having a systolic blood pressure>180mm Hg, total cholesterol (TC)>8mmol/l, TC/HDL ratio>8 or an abnormal ECG will be consulted by a cardiologist.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the change in the average 24 hour mean arterial blood<br /><br>pressure at 6 months relative to baseline.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study parameters include change in cholesterol levels at 6 months<br /><br>relative to baseline.</p><br>