Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data

Healthy Volunteers Clinical Trial

— LabStud_MSI  

Official title:

Laborstudie Zur Aufnahme Spektraler Und Photoplethysmographischer Daten

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348512
• Other study ID #: LabStud_MSI/iPPG
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: University of Leipzig
• Contact: Ines Gockel, Prof. Dr.
• Phone: +49 341 97
• Email: chi2[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• spectral imaging
non-contact, non-invasive hyperspectral and multispectral imaging without a diagnostic test
• photoplethysmography
non-invasive pulse oximetry without a diagnostic test

Locations

Country	Name	City	State
Germany	Department of Visceral, Transplantation, Vascular and Thoracic Surgery	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RGB video data	true color video data (10 bit per channel [red, green, blue]) from tongues and fingers	16 minutes
Primary	hyperspectral data	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
Primary	multispectral video data	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
Primary	plethysmographic wave	numerical value in arbitrary values representing the amount of transmitted/reflected light over time through fingers or earlobes or from the forehead	5 minutes
Primary	pulse	frequency in bpm (beats per minute) or Hz (Hertz)	5 minutes
Primary	pulsation index	ratio between pulsating and non-pulsating tissue components in %	5 minutes
Primary	SpO2	oxygenation of arterial blood in %, measured with a pulse oximeter	5 minutes