Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data (LabStud_MSI)

December 12, 2022 updated by: Ines Gockel, University of Leipzig

Laborstudie Zur Aufnahme Spektraler Und Photoplethysmographischer Daten

Laboratory study on healthy volunteers to acquire spectral video data from the tongue and fingers as well as photoplethysmographic data from the forehead, fingers, and earlobes to evaluate and optimize algorithms for imaging photoplethysmography (iPPG) and multispectral imaging (MSI)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Recruiting
        • Department of Visceral, Transplantation, Vascular and Thoracic Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers >= 18 years

Description

Inclusion Criteria:

  • healthy volunteers >= 18 years old

Exclusion Criteria:

  • pregnant and nursing women
  • persons unable to consent
  • persons with tattoos or diseases on the tongue, finger, ear, or forehead
  • narcoleptics
  • epileptics
  • persons with arterial hypertension, peripheral arterial disease, anemia, Raynaud syndrome, autoimmune vasculitides, Takayasu arteritis, venous insuffiencies, microangiopathy, diabetic vasculopathy, scleroderma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RGB video data
Time Frame: 16 minutes
true color video data (10 bit per channel [red, green, blue]) from tongues and fingers
16 minutes
hyperspectral data
Time Frame: 16 minutes
false color parameter images, representing the oxygenation in %; the perfusion; the hemoglobin, water, and fat content of tissue in arbitrary units betwenn 0 and 100 from tongues and fingers (imaged areas have to correspond to RGB video data)
16 minutes
multispectral video data
Time Frame: 16 minutes
true color video data (10 bit per channel [red, green, blue]) from tongues and fingers (imaged areas have to correspond to RGB video data)
16 minutes
plethysmographic wave
Time Frame: 5 minutes
numerical value in arbitrary values representing the amount of transmitted/reflected light over time through fingers or earlobes or from the forehead
5 minutes
pulse
Time Frame: 5 minutes
frequency in bpm (beats per minute) or Hz (Hertz)
5 minutes
pulsation index
Time Frame: 5 minutes
ratio between pulsating and non-pulsating tissue components in %
5 minutes
SpO2
Time Frame: 5 minutes
oxygenation of arterial blood in %, measured with a pulse oximeter
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Ines Gockel, Prof. Dr., University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • LabStud_MSI/iPPG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual data will not be shared. However, results are planned to be published in a scientific journal in a completely anonymized manner.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on spectral imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe