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

NCT ID: NCT01690429

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Keywords

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Arousal detection Pulse Wave Amplitude Obstructive Sleep Apnea Daytime sleepiness Cardiorespiratory risk

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OSA Patients

Group Type OTHER

Somnocheck micro

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Obstructive Sleep Apnea (AHI \>5)

Exclusion Criteria

* Suspected acute cardiac, pulmonary or neurologic disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weinmann Geräte für Medizin GmbH + Co. KG

INDUSTRY

Sponsor Role collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role lead

Responsible Party

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Karl Heinz Ruehle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl Heinz Rühle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen

Locations

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Helios Klinik Hagen

Hagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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SOMNOcheck-2012

Identifier Type: -

Identifier Source: org_study_id