Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

13 oktober 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

33

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Red LED
Light emitting diodes, 670 nm, 50 mW/cm2, Quantum Warp10 (Quantum Devices Inc, Barneveld, WI, USA); RESPeRATE; Heat/cold provocation
Apparaat: 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.
Apparaat: Quantum Warp10 (Red LED)
Ander: 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.
Actieve vergelijker: Near Infrared LED
Light emitting diodes, 830 nm, 55 mW/cm2, Omnilux new-U (Photomedex, Horsham, PA, USA); RESPeRATE; Heat/cold provocation
Apparaat: 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.
Ander: 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.
Apparaat: Omnilux new-U (Near Infrared LED)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
MRT as measured from finger Photoplethysmography in response to changes in breathing rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Afeka, The Tel-Aviv Academic College of Engineering

Medewerkers

Sheba Medical Center

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2015

Primaire voltooiing (Werkelijk)

1 juni 2016

Studie voltooiing (Werkelijk)

1 oktober 2016

Studieregistratiedata

Eerst ingediend

28 juli 2015

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2015

Eerst geplaatst (Schatting)

18 augustus 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

17 oktober 2016

Laatste update ingediend die voldeed aan QC-criteria

13 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2080-15-SMC

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren