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

13 oktober 2016 uppdaterad av: Afeka, The Tel-Aviv Academic College of Engineering

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

33

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Israel
      • Tel Aviv, Israel
        • Afeka, Tel-Aviv Academic College of Engineering

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Healthy males and females, between 18 and 65 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Red LED
Light emitting diodes, 670 nm, 50 mW/cm2, Quantum Warp10 (Quantum Devices Inc, Barneveld, WI, USA); RESPeRATE; Heat/cold provocation
Enhet: RESPeRATE (Paced Breathing)
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.
Enhet: Quantum Warp10 (Red LED)
Övrig: Heat/cold provocation
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.
Aktiv komparator: Near Infrared LED
Light emitting diodes, 830 nm, 55 mW/cm2, Omnilux new-U (Photomedex, Horsham, PA, USA); RESPeRATE; Heat/cold provocation
Enhet: RESPeRATE (Paced Breathing)
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.
Övrig: Heat/cold provocation
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.
Enhet: Omnilux new-U (Near Infrared LED)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
MRT as measured from finger Photoplethysmography in response to changes in breathing rate
Tidsram: Change from baseline to up to 1 minute after termination of 2 minutes of constant breathing rate (15, 10, and 6 breath/min)
Change from baseline to up to 1 minute after termination of 2 minutes of constant breathing rate (15, 10, and 6 breath/min)
MRT as measured from finger Photoplethysmography in response to light source
Tidsram: Change from immediately before exposure to light source to up to 10 minutes after exposure to light source
Change from immediately before exposure to light source to up to 10 minutes after exposure to light source
MRT as measured from finger Photoplethysmography in response to temperature changes
Tidsram: 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
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

Sekundära resultatmått

Resultatmått
Tidsram
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler
Tidsram: 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
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
Transcutaneous oxygen pressure (tcpO2 in mmHg)
Tidsram: 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
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Afeka, The Tel-Aviv Academic College of Engineering

Samarbetspartners

Sheba Medical Center

Utredare

  • Huvudutredare: Moshe Halak, MD, Sheba medical center
  • Studierektor: Zehava Blechman, PhD, Afeka, Tel-Aviv Academic College of Engineering

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2015

Primärt slutförande (Faktisk)

1 juni 2016

Avslutad studie (Faktisk)

1 oktober 2016

Studieregistreringsdatum

Först inskickad

28 juli 2015

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2015

Första postat (Uppskatta)

18 augusti 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 oktober 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 oktober 2016

Senast verifierad

1 oktober 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2080-15-SMC

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

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