Hypoxia at Multiple Wavelengths of Light

March 6, 2014 updated by: Nonin Medical, Inc

Effect of Induced Hypoxia at Multiple Wavelengths

The purpose of the study is to assess the effect of progressive, incremental hypoxia at multiple wavelengths of light.

Study Overview

Status

Completed

Conditions

Detailed Description

No additional information is required.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • HPPL Duke Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

  • Is between 18 and 35 years of age
  • Is American Society Anesthesiologist status 1
  • Has a BMI between 18 and 30

Exclusion Criteria:

  • Currently taking any medications other than birth control pills
  • Has participate in an investigational drug study within one month prior to the start of the study
  • Fails the Allen's Test to confirm patency of the colateral artery
  • Subject is female with a positive pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study termination
  • Has a positive urine continine or drug test
  • Has an reported allergy to Lidocaine
  • Has anemia or other hemoglobinopathy
  • Has a room air saturation less than 95% by pulse oximetry
  • Has an abnormal EKG
  • Has an abnormal pulmonary function test via spirometry
  • Is intolerant to a breathing mask apparatus
  • Has a COHb greater than 3%, or MetHb greater than 2%
  • Has another condition, which in the opinion of the principle investigator would not be suitable for participation in the study
  • Is unwilling or unable to provide informed consent or comply with the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light
Time Frame: Up to 8 weeks
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nonin Medical, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QATP2552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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