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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357523
Other study ID # 05.04.2017-1-AFK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date December 31, 2019

Study information

Verified date November 2021
Source Afeka, The Tel-Aviv Academic College of Engineering
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler


Description:

This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Years to 45 Years
Eligibility Inclusion Criteria: 1. Healthy males and females, between 23 and 45 years of age. 2. Willing to sign informed consent Exclusion Criteria: 1. Currently smoking 2. Any abnormal skin condition in the area of light irradiation. 3. Pregnant having given birth less than 3 months ago, and/or breastfeeding. 4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen. 5. Having any illness that might affect the vasculature, such as diabetes (type I or II) 6. Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders. 7. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Omnilux new-U (Red LED)
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated
Omnilux new-U (Near infrared LED)
The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated
RESPeRATE
The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm
Heating bag
Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds

Locations

Country Name City State
Israel Afeka, Tel-Aviv Academic College of Engineering Tel Aviv

Sponsors (2)

Lead Sponsor Collaborator
Afeka, The Tel-Aviv Academic College of Engineering Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Capillary blood flow Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler (Biopac™ System, Inc, USA). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment. Up to 1 hour
Secondary Temperature distribution over hands measured by thermography Thermographic images will be photographed with a FLIR camera and temperature distribution will be analysed. Photos will be taken every minute from baseline to end of experiment. Up to 1 hour
Secondary Tissue oxygenation (tcPO2) Tissue oxygenation (tcPO2) measured by electrodes mounted on both hands (Perimed™ system, Sweden). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment. Up to 1 hour
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