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Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690429
First Posted: September 21, 2012
Last Update Posted: November 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Weinmann Geräte für Medizin GmbH + Co. KG
Information provided by (Responsible Party):
Karl Heinz Ruehle, Institut für Pneumologie Hagen Ambrock eV
September 19, 2012
September 21, 2012
November 14, 2013
June 2012
December 2012   (Final data collection date for primary outcome measure)
pulse wave amplitude (PWA) [ Time Frame: 8 hours ]
Same as current
Complete list of historical versions of study NCT01690429 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe
Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA) from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is a surrogate marker for waking reactions (arousal) which eventually will contribute to assess sleep disruption and resulting performance deterioration. Arousal and performance deterioration and its possible improvement under continuous positive airway pressure (CPAP) therapy will be determined in this study.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Obstructive Sleep Apnea
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.
OSA Patients
Intervention: Device: Somnocheck micro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obstructive Sleep Apnea (AHI >5)

Exclusion Criteria:

  • Suspected acute cardiac, pulmonary or neurologic disease
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01690429
SOMNOcheck-2012
No
Not Provided
Not Provided
Karl Heinz Ruehle, Institut für Pneumologie Hagen Ambrock eV
Institut für Pneumologie Hagen Ambrock eV
Weinmann Geräte für Medizin GmbH + Co. KG
Principal Investigator: Karl Heinz Rühle, Prof. Dr. Helios Klinik Hagen
Institut für Pneumologie Hagen Ambrock eV
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP