NCT01957891

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

September 19, 2013

Last Update Submit

March 6, 2014

Conditions

Hypoxia in Healthy Individuals

Keywords

HypoxiaMultiple wavelengths

Outcome Measures

Primary Outcomes (1)

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

    Up to 8 weeks

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HPPL Duke Univeristy

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David MacLeod, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

US(1)