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Completed

NCT Number: NCT01626274

Long Term Vital Parameter Monitoring (LAVIMO)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurological Clinic , University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

LAVIMO in- ear sensor system

Device

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 names: Photoplethysmographic microoptic reflective microsensor

Primary outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Long Term Vital Parameter Monitoring Pilot Study to Evaluate Measurement Data Via In-ear Sensor in Comparison to Standard Polysomnography in Sleep Laboratory

Acronym: LAVIMO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 22, 2012
Registry last updated
Nov 27, 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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