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High-quality Image (NIR and RGB) Dataset Synchronized With Contact Vital Sings Recordings and Clinical Data of Stratified Healthy Population. Algorithms and AI Models to Obtain a Set of Vital Signs Image-based.

NCT05947721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-07-17

No results posted yet for this study

Summary

The objective of this study is to collect an image dataset of healthy and pathological population with a characterization of the potential factors that may influence the methodologies used to obtain vital signs. To this end, an observational study of qualitative and quantitative data collection through cameras, contact recording technologies (gold standards) and questionnaires has been proposed.

Based on these data, the specific objectives of this study are as follows:

* To determine the differences according to the factors analysed.
* Develop/fine-tune algorithms/AI models to obtain quality rPPG/rBCG signals.
* Fine-tune models to obtain the main vital signs as HR, RR, SpO2 and BP from image-based-data.

The dataset (namely Freyja/IBV-Dataset) is composed of 73 subjects (35 females and 38 males) with ages ranging from 18 to 85, representation in the 6 skin phototypes according to the Fitzpatrick scale (1), and BMI ranging from 15 to 40. In order to determine the sample size, specific ranges have been defined for each of the intrinsic subject factors and all possible combinations have been covered. The number of subjects defined for each combination was based on the percentage it represents in the Spanish population according to the INE (Instituto Nacional de Estadística).

The subjects will be recruited through the own databases of participants in previous trials of the Institute of Biomechanics of Valencia, who have given written consent to be contacted in order to request their participation in any other study where their profile may fit.

The surveys will be included in an online platform specialized in the realization of questionnaires. This data will be exported for further storage, management and analysis. All information will be anonymized for processing and analysis, and may be used under the terms and conditions dictated by the current legal framework.

To participate in the study, participants must accept the terms and conditions included in the first page of the survey embedded in the online platform, where the aspects related to the study methodology and the use of them data are exposed.

Conditions

  • Healthy Population (HP)

Sponsors & Collaborators

  • Instituto de Biomecanica de Valencia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05947721 on ClinicalTrials.gov