Prospective cohort study on the effect of surgical treatment of obstructive sleep apnea syndrome on blood pressure (and other cardiovascular risk factors).

Prospective cohort study on the effect of surgical treatment of obstructive sleep apnea syndrome on blood pressure (and other cardiovascular risk factors). - ESTOSASBP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30534

Enrollment

100

Registered

2007-07-17

Start date

2007-04-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

bloeddruk obstructive sleep apnea syndrome sleep disordered breathing

Interventions

OSAS surgery

the principal interventions are: 1) Nose and sinus surgery to increase nasal passage, in case of decreased nasal passage

2) If the obstruction is on palate-uvula-tonsil level, therapeutic options consist of radiofrequent ther-motherapy, laser-assisted uvuloplasty, uvulopalatopharyngoplasty (UPPP), with or without tons

3) while in retrolingual obstruction surgical options are radiofrequency of the tongue base or hyoid sus-pension. In case of severe OSAS and multilevel obstruction, multilevel surgery in one tempo i

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Epsworth Sleepiness Scale (ESS) >9 Apnea Hypopnea Index(AHI) * 15

Exclusion criteria

Exclusion criteria: Patients with an AHI180mm Hg, total cholesterol (TC)>8mmol/l, TC/HDL ratio>8 or an abnormal ECG will be consulted by a cardiologist.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change in the average 24 hour mean arterial blood pressure at 6 months relative to baseline.	—

Secondary

Measure	Time frame
Secundary study parameters include change in cholesterol levels at 6 months relative to baseline.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)