Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea |
Device: Somnocheck micro |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| OSA Patients |
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.
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Obstructive Sleep Apnea (AHI >5)
Exclusion Criteria:
- Suspected acute cardiac, pulmonary or neurologic disease
Contacts and Locations| Contact: Georg Nilius, PD DR med | 0049 2331 974 ext 2000 | georg.nilius@helios-kliniken.de |
| Contact: Ulrike Domanski | 0049 2331 974 ext 2080 | ulrike.domanski@helios-kliniken.de |
| Germany | |
| Helios Klinik Hagen | Recruiting |
| Hagen, NRW, Germany, 58091 | |
| Contact: Georg Nilius, PD Dr med 0049 2331 974 ext 2000 georg.nilius@helios-kliniken.de | |
| Sub-Investigator: Oezkan Kalem | |
| Principal Investigator: | Karl Heinz Rühle, Prof. Dr. | Helios Klinik Hagen |
More Information
No publications provided
| Responsible Party: | Karl Heinz Ruehle, Principal Investigator, Institut für Pneumologie Hagen Ambrock eV |
| ClinicalTrials.gov Identifier: | NCT01690429 History of Changes |
| Other Study ID Numbers: | SOMNOcheck-2012 |
| Study First Received: | September 19, 2012 |
| Last Updated: | September 21, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Institut für Pneumologie Hagen Ambrock eV:
|
Arousal detection Pulse Wave Amplitude Obstructive Sleep Apnea Daytime sleepiness Cardiorespiratory risk |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013