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Completed

NCT Number: NCT01690429

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstructive Sleep Apnea (AHI >5)

Exclusion criteria

  • Suspected acute cardiac, pulmonary or neurologic disease

Treatment and study plan

Somnocheck micro

Device

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.

Primary outcomes

  1. pulse wave amplitude (PWA)

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • Weinmann Geräte für Medizin GmbH + Co. KG

Registry information

Official study title

Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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