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Completed

NCT Number: NCT02527070

Evaluating the State of Microvessels by Minimum Rise Time (MRT01)

Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. The objective of the current study is to investigate a potential relationship between MRT (minimum rise time, in time units) a measure derived from PPG and the state of microvessels.

This study includes a 1-2 hour single session per subject during which PPG and other microvascular and systemic variables will be monitored in response to non-invasive interventions that are known to elicit microvascular responses.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, Israel

About this study

Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. A major limitation of PPG is the lack of a quantitative method for calibrating this signal. A method that provides an absolute measure (in time units) called 'minimum rise time' (MRT) was published in 1985 by Dr. Benjamin Gavish, one of the study investigators. However, a possible relationship between MRT and the state of arterioles that determines the microvascular flow has never been investigated. Such relationship, if validated, could have clinical impact in noninvasive diagnosis of vascular diseases and monitoring microvascular response to treatments that affect at both clinic and home setting.

The objective of the current study is to investigate a potential relationship between variations of MRT (minimum rise time, in time units) and microcirculatory variables induced by interventions that are expected to have acute effect on the state of arterioles and the tissue oxygenation.

This study includes a single 1-2 hour session per subject, during which PPG and other microvascular and systemic variables will be monitored in healthy volunteers 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, and local temperature changes. The experimental sessions will be conducted at the Afeka College by the study investigators.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males and females, between 18 and 65 years of age.
  • Willing to sign informed consent.

Exclusion criteria

  • Currently smoking
  • Any abnormal skin condition in the area of light irradiation.
  • Pregnant having given birth less than 3 months ago, and/or breastfeeding.
  • 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.
  • Having any illness that might affect the vasculature, such as diabetes (type I or II)
  • Suffering from significant concurrent illness, such as cardiac disorders, , or pertinent neurological disorders.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Treatment and study plan

RESPeRATE (Paced Breathing)

Device

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.

Quantum Warp10 (Red LED)

Device

Omnilux new-U (Near infrared LED)

Device

Heat/cold provocation

Other

Immersion of one foot in a warm water bath ( 43-45 degrees C) for few seconds and then immersion of the same foot in cold water bath (5-7 degrees C) for 1 min.

Primary outcomes

  1. MRT as measured from finger Photoplethysmography in response to changes in breathing rate

    Time frame: Change from baseline to up to 1 minute after termination of 2 minutes of constant breathing rate (15, 10, and 6 breath/min)

  2. MRT as measured from finger Photoplethysmography in response to light source

    Time frame: Change from immediately before exposure to light source to up to 10 minutes after exposure to light source

  3. MRT as measured from finger Photoplethysmography in response to temperature changes

    Time frame: Change from immediately before exposure to temperature provocations to up to 2 minutes after exposure to warm water, and up to 2 minutes after exposure to cold water

Secondary outcomes

  1. Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler

    Time frame: At baseline, 1 minute after each changes in breathing rate, 5 and 10 minutes after exposure to light source, 1 minutes after each exposure to temperature changes

  2. Transcutaneous oxygen pressure (tcpO2 in mmHg)

    Time frame: At baseline, 1 minute after each changes in breathing rate, 5 and 10 minutes after exposure to light source, 1 minutes after each exposure to temperature changes

Sponsors and collaborators

Lead sponsor

Afeka, The Tel-Aviv Academic College of Engineering

Other

Collaborators

  • Sheba Medical Center

Registry information

Official study title

Evaluating an Optical Index (Minimum Rise Time) as a Measure for the State of Microvessels

Acronym: MRT01

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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