Long Term Vital Parameter Monitoring (LAVIMO)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: LAVIMO in- ear sensor system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: in-ear sensor<br>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<br>* 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<br>* Other names: Photoplethysmographic microoptic reflective microsensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory | 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 | one night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polysomnography, Long term vital signs monitoring, In-ear sensor system, Photoplethysmographic micro-optic device, High wearing comfort