Long Term Vital Parameter Monitoring (LAVIMO)

NCT01626274 | Completed

• 2 other identifiers: CTC-A_10-016EK 231/10
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

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

Outcome Measures

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

  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

Study Arms (1)

Device: in-ear sensor

EXPERIMENTAL

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

Interventions

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

Also known as: Photoplethysmographic microoptic reflective microsensor

Device: in-ear sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Neurological Clinic , University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Johannes Schiefer, MD

  Neurological Clinic, University Hospital Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

DE (1)