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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Somnocheck micro
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Arousal detection, Pulse Wave Amplitude, Obstructive Sleep Apnea, Daytime sleepiness, Cardiorespiratory risk

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obstructive Sleep Apnea (AHI >5)

Exclusion Criteria:

  • Suspected acute cardiac, pulmonary or neurologic disease

Sites / Locations

  • Helios Klinik Hagen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

OSA Patients

Arm Description

Outcomes

Primary Outcome Measures

pulse wave amplitude (PWA)

Secondary Outcome Measures

Full Information

First Posted
September 19, 2012
Last Updated
November 13, 2013
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01690429
Brief Title
Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
Official Title
Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Arousal detection, Pulse Wave Amplitude, Obstructive Sleep Apnea, Daytime sleepiness, Cardiorespiratory risk

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSA Patients
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Somnocheck micro
Intervention Description
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 Outcome Measure Information:
Title
pulse wave amplitude (PWA)
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obstructive Sleep Apnea (AHI >5) Exclusion Criteria: Suspected acute cardiac, pulmonary or neurologic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Heinz Rühle, Prof. Dr.
Organizational Affiliation
Helios Klinik Hagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany

12. IPD Sharing Statement

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

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