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

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.
ClinicalTrials.gov Identifier: NCT01690429
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : November 14, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obstructive Sleep Apnea Device: Somnocheck micro

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe
Study Start Date : June 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. pulse wave amplitude (PWA) [ Time Frame: 8 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obstructive Sleep Apnea (AHI >5)

Exclusion Criteria:

  • Suspected acute cardiac, pulmonary or neurologic disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690429


Locations
Germany
Helios Klinik Hagen
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Weinmann Geräte für Medizin GmbH + Co. KG
Investigators
Principal Investigator: Karl Heinz Rühle, Prof. Dr. Helios Klinik Hagen
More Information

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
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by Karl Heinz Ruehle, 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 Wake Disorders
Nervous System Diseases