Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe|
- pulse wave amplitude (PWA) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Device: Somnocheck micro
Study nights in sleep lab with standard polysomnography plus Somnocheck micro. The Somnocheck micro is a device with pulse oxymetry and nasal cannula, which can be worn like a wristwatch. It records information about sleep disordered breathing, oxygen saturation, and pulse wave.
Patients from the sleep laboratory with verified obstructive sleep apnea syndrome (OSAS) will be asked to participate in this study.
A device is used to determine autonomic arousal over night (SOMNOcheck micro). The Somnocheck micro records oxygen saturation as well as pulse frequency and breathing, and calculates an autonomic arousal index (AAI). Somnocheck measurements will take place in two nights (baseline and with CPAP) and parallel to a standard polysomnography (PSG). The PSG provides data to analyze the arousal frequency according to ASDA rules, which will then be compared to the AAI.
Performance is determined twice (prior and after CPAP therapy) by the use of a steering simulator programme (DASS). Differences in arousal will be correlated with differences in performance (deviation from the road, reaction time). The subjects are also asked to fill out the Epworth Sleepiness Scale (ESS) twice, prior and after therapy. Aim is to compare Somnocheck and PSG measurements and daytime sleepiness with DASS and ESS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690429
|Helios Klinik Hagen|
|Hagen, NRW, Germany, 58091|
|Principal Investigator:||Karl Heinz Rühle, Prof. Dr.||Helios Klinik Hagen|