Hypoxia at Multiple Wavelengths of Light

NCT ID: NCT01957891

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

No additional information is required.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxia in Healthy Individuals

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nonin Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David MacLeod, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HPPL Duke Univeristy

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QATP2552

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hypoxic Preconditioning on Patients
NCT02966418 COMPLETED NA