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Clinical Trials/NCT01957891
NCT01957891CompletedNot Applicable

Effect of Induced Hypoxia at Multiple Wavelengths

Nonin Medical, Inc1 site in 1 country26 target enrollmentStarted: September 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light

Study Overview

Brief Summary

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

Detailed Description

No additional information is required.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light

Time Frame: Up to 8 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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