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Long Term Vital Parameter Monitoring (LAVIMO)

This study is currently recruiting participants.
Verified June 2012 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01626274
First received: June 20, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a photoplethysmographic device for reflective mode measurements of the optical damping upper skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate variability, breathing and arterial blood oxygenation are monitored in patients with sleep apnoea and compared to measurements of standard polysomnography of these patients during one night in the sleep laboratory.


Condition Intervention
Sleep Apnea, Obstructive
 Device: LAVIMO in- ear sensor system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Long Term Vital Parameter Monitoring Pilot Study to Evaluate Measurement Data Via In-ear Sensor in Comparison to Standard Polysomnography in Sleep Laboratory

Resource links provided by NLM:

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

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory [ Time Frame: one night ] [ Designated as safety issue: No ]
    during one polysomnographic night in sleep laboratory the patient will receive the LAVIMO in- ear sensor system and vital parameters like heart rate, heart rate variability, breathing and oxygen saturation will be monitored. Subsequently the data will be processed and compared to the standard polysomnographic data


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device: in-ear sensor
Patients who routinely undergo a polysomnography night (1 night) are monitored via in-ear sensor which will be embedded in the auditory canal. During this night vital signs parameters are monitored, processed and subsequently compared to the polysomnography data.
 Device: LAVIMO in- ear sensor system
Long term vital signs parameters like heart rate, heart rate variability, breathing and oxygen saturation are measured via in- ear sensor system during 1 polysomnographic night
Other Name: Photoplethysmographic microoptic reflective microsensor

Detailed Description:

In 20 patients who routinely have to undergo a polysomnographic night in sleep laboratory LAVIMO measurements like heart rate, heart rate variability, breathing and arterial blood oxygenation are performed parallel to standard polysomnography measurements and subsequently compared to the data of the standard polysomnography. The LAVIMO sensor system consists of the in- ear sensor, the electronics and a PC; the individually formed sensor is embedded into an ear mould for proper fit inside the ear canal. Inside two LEDs emit light into the adjacent skin at 760 and 905 nm wavelengths. The intensity of the backscattered light is detected by a photo detector. In the electronics, the control signals for the LEDs are provided, as well as the photo detector signal is further processed and A-D converted. The electronics also provide a wireless connection to the PC via bluetooth. Data recording, post processing and displaying are tasks of the PC. The feasibility of non- intrusive 24 hours and non-invasive measurements like heart rate, heart rate variability, breathing and oxygen saturation is proved via this minimized sensor and electronics placed at a suitable place at the body guaranteeing high wearing comfort. This includes a wireless data communication for unrestricted mobility. Subsequently the data are compared to the standard polysomnography data to extract vital signs or for example to recognize possible phases of sleep apnoea. The goal in future refering to preventive medical monitoring will be early detection of risk factors for patient`s health and improvement of living conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients > 18 years who routinely have to undergo a polysomnography night
  • sleep apnoea patient
  • able to give informed consent

Exclusion Criteria:

  • dementia
  • cochlea implant
  • severe lung diseases
  • allergy against material of the sensor
  • inflammation of the middle ear
  • inflammation of auditory canal
  • occlusion because of cerumen
  • electric implants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626274

Contacts
Contact: Johannes Schiefer, MD 0049 241 80 ext 89630 jschiefer@ukaachen.de
Contact: Sigrid Gloeggler, M. Sc. 0049 241 80 ext 80202 sgloeggler@ukaachen.de

Locations
Germany
Neurological Clinic , University Hospital Recruiting
Aachen, North Rhine Westphalia, Germany, 52074
Contact: Johannes Schiefer, MD     0049 241 80 ext 89630     jschiefer@ukaachen.de    
Contact: Sigrid Gloeggler, M. Sc.     0049 241 80 ext 80202     sgloeggler@ukaachen.de    
Principal Investigator: Johannes Schiefer, MD            
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Johannes Schiefer, MD Neurological Clinic, University Hospital Aachen
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01626274     History of Changes
Other Study ID Numbers: CTC-A_10-016, EK 231/10
Study First Received: June 20, 2012
Last Updated: June 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Polysomnography
Long term vital signs monitoring
In-ear sensor system
Photoplethysmographic micro-optic device
High wearing comfort

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013