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

NCT02527070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2016-10-17

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DEVICE

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.

DEVICE

Quantum Warp10 (Red LED)

DEVICE

Omnilux new-U (Near Infrared LED)

OTHER

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.

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Afeka, The Tel-Aviv Academic College of Engineering

    lead OTHER

Principal Investigators

  • Moshe Halak, MD · Sheba Medical Center

  • Zehava Blechman, PhD · Afeka, Tel-Aviv Academic College of Engineering

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-06-30
Completion
2016-10-31

Countries

  • Israel

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 NCT02527070 on ClinicalTrials.gov