Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data

NCT05348512 | Unknown

• 1 other identifier: LabStud_MSI/iPPG
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• RGB video data

  true color video data (10 bit per channel \[red, green, blue\]) from tongues and fingers

  16 minutes

• 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

• 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

• 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

• pulse

  frequency in bpm (beats per minute) or Hz (Hertz)

  5 minutes

• pulsation index

  ratio between pulsating and non-pulsating tissue components in %

  5 minutes

• SpO2

  oxygenation of arterial blood in %, measured with a pulse oximeter

  5 minutes

Interventions

spectral imaging OTHER

non-contact, non-invasive hyperspectral and multispectral imaging without a diagnostic test

photoplethysmography OTHER

non-invasive pulse oximetry without a diagnostic test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers \>= 18 years

You may qualify if:

• healthy volunteers \>= 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

Department of Visceral, Transplantation, Vascular and Thoracic Surgery

Leipzig, 04103, Germany

RECRUITING

Study Officials

• Ines Gockel, Prof. Dr.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Gockel, Prof. Dr.

CONTACT

+49 341 97; chi2@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med., MBA

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 27, 2022
• Study Start: August 22, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)