Long Term Vital Parameter Monitoring (LAVIMO)

NCT ID: NCT01626274

Last Updated: 2013-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-02-28

Brief Summary

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

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Polysomnography; Long term vital signs monitoring; In-ear sensor system; Photoplethysmographic micro-optic device; High wearing comfort

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LAVIMO in- ear sensor system

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Photoplethysmographic microoptic reflective microsensor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes Schiefer, MD

Role: PRINCIPAL_INVESTIGATOR

Neurological Clinic, University Hospital Aachen

Locations

Neurological Clinic , University Hospital

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

EK 231/10

Identifier Type: OTHER

Identifier Source: secondary_id

CTC-A_10-016

Identifier Type: -

Identifier Source: org_study_id