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

This study has been completed.
Sponsor:
Collaborator:
Weinmann Geräte für Medizin GmbH + Co. KG
Information provided by (Responsible Party):
Karl Heinz Ruehle, Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier:
NCT01690429
First received: September 19, 2012
Last updated: November 13, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Institut für Pneumologie Hagen Ambrock eV:

Primary Outcome Measures:
  • pulse wave amplitude (PWA) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 2012
Study Completion Date: December 2012
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.

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
Criteria

Inclusion Criteria:

  • Obstructive Sleep Apnea (AHI >5)

Exclusion Criteria:

  • Suspected acute cardiac, pulmonary or neurologic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

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: November 13, 2013
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 April 17, 2014