Hypoxia in Healthy IndividualsNCT01957891
Hypoxia at Multiple Wavelengths of Light
An observational study of Hypoxia in Healthy Individuals, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
The purpose of the study is to assess the effect of progressive, incremental hypoxia at multiple wavelengths of light. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia in Healthy Individuals
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Is between 18 and 35 years of age
- Is American Society Anesthesiologist status 1
- Has a BMI between 18 and 30
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
No additional information is required.
- Conditions
- Hypoxia in Healthy Individuals
- Keywords
- Hypoxia, Multiple wavelengths
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia in Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David MacLeod, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957891
- Sponsor's protocol ID
- QATP2552
- Status last verified
- Mar 2014
- First submitted
- 19 Sep 2013
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Induced Hypoxia at Multiple Wavelengths
- ClinicalTrials.gov ID
- NCT01957891
- Acronym / sponsor ID
- QATP2552
- Conditions
- Hypoxia in Healthy Individuals
- Keywords
- Hypoxia, Multiple wavelengths
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Is between 18 and 35 years of age
- Is American Society Anesthesiologist status 1
- Has a BMI between 18 and 30
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David MacLeod, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia in Healthy Individuals, run by Nonin Medical, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of progressive, incremental hypoxia at multiple wavelengths of light (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.