HealthyNCT03106376
Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers
A study testing 16% O2 gas in breathed air and 26% O2 gas in breathed air in people with Healthy, run by Mclean Hospital at 1 site in United States.
Trial summary
This study evaluates the impact of hypoxic and hyperoxic breathing on measures of brain redox balance and metabolism in healthy individuals. All participants will undergo an MRI scan during administration of air mixtures with different oxygen concentrations to collect the brain measures. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 16% O2 gas in breathed air and 26% O2 gas in breathed air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2023to 29 Aug 2023
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female individuals age between 18 and 40 years old
- BMI between 19 and 29 kg/m2
- Having capacity to consent to the study
Who cannot join
- Under 18 or over 40 Family history of psychiatric illness among first degree relatives (parents, siblings, or children)
- Delirium secondary to medical illness
- Any contraindication to MR scan, including claustrophobia, pregnancy, etc.
- Medical condition that might endanger the subject during or after a blood draw (e.g. hemophilia)
- Significant medical or neurological illness
- Prior high altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis Born at altitudes greater than 2,100 m (~7,000 ft) Systemic disease with or without any functional limitation; including controlled hypertension controlled diabetes without systemic effects any cardiac conditions with or without functional limitation, such as, coronary artery disease or valve disease Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), less than six weeks postpartum, or planning to conceive during the study period.
- Women who are not willing to receive serum pregnancy tests Active smoking and tobacco chewers. Volunteers may be enrolled if they quit smoking for more than 1 year.
- Excess alcohol use: more than ½ L/day of wine consumption or equivalent Any current medication use except oral contraceptives. Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areas that are more than 1,200 m for more than four days within the last 2 months Anemia, as defined by hemoglobin < 10g/dL Abnormal hemoglobin (e.g. presence of hemoglobin S) Evidence of apnea or other sleeping disorders Evidence of asthma Lower respiratory infection within the last 30 days Not willing to have blood drawn from an arm vein each test day of the study Claustrophobia (inability to tolerate MRI scan or wear a facemask) Currently enrolled in another research study Facial abnormalities that would preclude proper use of a face mask Hb<12
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the impact of hypoxic and hyperoxic breathing on measures of brain redox balance and metabolism in healthy individuals. All participants will undergo an MRI scan during administration of air mixtures with different oxygen concentrations to collect the brain measures.
Read the detailed description
Molecular oxygen (O2) constitutes 21% of the air people breathe at sea level. But humans can safely be exposed to somewhat lower and higher concentrations of oxygen. The varying amounts of oxygen entering the body modulate the oxygen available in tissue, ultimately leading to change in redox balance and metabolism. The investigators recently developed non-invasive MRI-based techniques to quantify redox balance and ATP generation in the brain. These processes are thought to be abnormal in people with psychiatric disorders.
In this study, the investigators aim to manipulate the concentration of oxygen in the breathed air in 2 separate MRI scans on consecutive days (16% and 26%). The investigators anticipate that healthy individuals will demonstrate changes in brain redox balance and metabolism in response to these modulations.
- Conditions
- Healthy
- Being tested
- 16% O2 gas in breathed air, 26% O2 gas in breathed air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16% O2 gas in breathed airOther
Inspiratory gas mixtures: Hypoxic inspiratory gas will be obtained by adding nitrogen (N2) to normobaric, normoxic air with medical N2 tanks.
Delivery of gas mixture: The gas mixture will be delivered by standard tight facemask.
26% O2 gas in breathed airOther
Inspiratory gas mixtures: Hyperoxic inspiratory gas will be obtained by adding oxygen (O2) to normobaric, normoxic air with medical O2 tanks.
Delivery of gas mixture: The gas mixture will be delivered by standard tight facemask.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | 16% O2 gas in breathed air for 30 minutes 26% O2 gas in breathed air for 30 minutes Receives: Other: 16% O2 gas in breathed air; Other: 26% O2 gas in breathed air |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAD+/NADH ratio
NAD+ and NADH concentrations are measured using 31P MRS scanning
Measured: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
Secondary outcomes (4)
CK Kf
Reaction rate of the creatine kinase enzyme measured using 31P MRS scanning
Measured: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
PCr
Phosphocreatine concentration measured using 31P MRS scanning
Measured: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
Pi
Inorganic phosphate concentration measured using 31P MRS scanning
Measured: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
ATP
ATP concentration measured using 31P MRS scanning
Measured: During 30 minute hypoxic/hyperoxic exposure portion of theMRS scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start29 Aug 2023 (estimated)
- Primary completion29 Aug 2023 (estimated)
- Study completion29 Aug 2023 (estimated)
Why it stopped: Study team has decided to focus on other projects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dost Ongur, Mclean Hospital
- Investigators
- Dost Ongur, MD PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106376
- Sponsor's protocol ID
- 2017P000328
- Status last verified
- Aug 2023
- First submitted
- 29 Mar 2017
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03106376
- Acronym / sponsor ID
- 2017P000328
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study team has decided to focus on other projects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 29 Aug 2023 (estimated)
- Primary completion
- 29 Aug 2023 (estimated)
- Study completion
- 29 Aug 2023 (estimated)
- First posted
- 10 Apr 2017 (actual)
- 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.
This study evaluates the impact of hypoxic and hyperoxic breathing on measures of brain redox balance and metabolism in healthy individuals. All participants will undergo an MRI scan during administration of air mixtures with different oxygen concentrations to collect the brain measures.
Detailed description
Molecular oxygen (O2) constitutes 21% of the air people breathe at sea level. But humans can safely be exposed to somewhat lower and higher concentrations of oxygen. The varying amounts of oxygen entering the body modulate the oxygen available in tissue, ultimately leading to change in redox balance and metabolism. The investigators recently developed non-invasive MRI-based techniques to quantify redox balance and ATP generation in the brain. These processes are thought to be abnormal in people with psychiatric disorders.
In this study, the investigators aim to manipulate the concentration of oxygen in the breathed air in 2 separate MRI scans on consecutive days (16% and 26%). The investigators anticipate that healthy individuals will demonstrate changes in brain redox balance and metabolism in response to these modulations.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Other: 16% O2 gas in breathed air, Other: 26% O2 gas in breathed air16% O2 gas in breathed air for 30 minutes 26% O2 gas in breathed air for 30 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female individuals age between 18 and 40 years old
- BMI between 19 and 29 kg/m2
- Having capacity to consent to the study
Key exclusion criteria (8 listed)
- Under 18 or over 40 Family history of psychiatric illness among first degree relatives (parents, siblings, or children)
- Delirium secondary to medical illness
- Any contraindication to MR scan, including claustrophobia, pregnancy, etc.
- Medical condition that might endanger the subject during or after a blood draw (e.g. hemophilia)
- Significant medical or neurological illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16% O2 gas in breathed airInspiratory gas mixtures: Hypoxic inspiratory gas will be obtained by adding nitrogen (N2) to normobaric, normoxic air with medical N2 tanks. Delivery of gas mixture: The gas mixture will be delivered by standard tight facemask. | Other | Healthy subjects |
| 26% O2 gas in breathed airInspiratory gas mixtures: Hyperoxic inspiratory gas will be obtained by adding oxygen (O2) to normobaric, normoxic air with medical O2 tanks. Delivery of gas mixture: The gas mixture will be delivered by standard tight facemask. | Other | Healthy subjects |
Primary outcome
NAD+/NADH ratio
Time frame: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
NAD+ and NADH concentrations are measured using 31P MRS scanning
4 secondary outcomes
CK Kf
Time frame: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
PCr
Time frame: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
Pi
Time frame: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan
ATP
Time frame: During 30 minute hypoxic/hyperoxic exposure portion of theMRS scan
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Dost Ongur, MD PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16% O2 gas in breathed air and 26% O2 gas in breathed air in people with Healthy, run by Mclean Hospital 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 8 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: withdrawn, as of the sponsor's last update on 30 Aug 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
NAD+/NADH ratio (time frame: During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan). 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 30 Aug 2023.