Back to results

Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers

Primary Purpose

Healthy

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

16% O2 gas in breathed air

26% O2 gas in breathed air

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

McLean Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy subjects

Arm Description

16% O2 gas in breathed air for 30 minutes 26% O2 gas in breathed air for 30 minutes

Outcomes

Primary Outcome Measures

NAD+/NADH ratio

NAD+ and NADH concentrations are measured using 31P MRS scanning

Secondary Outcome Measures

CK Kf

Reaction rate of the creatine kinase enzyme measured using 31P MRS scanning

PCr

Phosphocreatine concentration measured using 31P MRS scanning

Inorganic phosphate concentration measured using 31P MRS scanning

ATP

ATP concentration measured using 31P MRS scanning

Full Information

NCT ID

NCT03106376

First Posted

March 29, 2017

Last Updated

August 29, 2023

Sponsor

Mclean Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03106376

Brief Title

Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers

Official Title

Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Study team has decided to focus on other projects

Study Start Date

August 29, 2023 (Anticipated)

Primary Completion Date

August 29, 2023 (Anticipated)

Study Completion Date

August 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy subjects

Arm Type

Experimental

Arm Description

16% O2 gas in breathed air for 30 minutes 26% O2 gas in breathed air for 30 minutes

Intervention Type

Other

Intervention Name(s)

16% O2 gas in breathed air

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

26% O2 gas in breathed air

Intervention Description

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.

Primary Outcome Measure Information:

Title

NAD+/NADH ratio

Description

NAD+ and NADH concentrations are measured using 31P MRS scanning

Time Frame

During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan

Secondary Outcome Measure Information:

Title

CK Kf

Description

Reaction rate of the creatine kinase enzyme measured using 31P MRS scanning

Time Frame

During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan

Title

PCr

Description

Phosphocreatine concentration measured using 31P MRS scanning

Time Frame

During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan

Title

Description

Inorganic phosphate concentration measured using 31P MRS scanning

Time Frame

During 30 minute hypoxic/hyperoxic exposure portion of the MRS scan

Title

ATP

Description

ATP concentration measured using 31P MRS scanning

Time Frame

During 30 minute hypoxic/hyperoxic exposure portion of theMRS scan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dost Ongur, MD PhD

Organizational Affiliation

Mclean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

McLean Hospital

City

Belmont

State/Province

Massachusetts

ZIP/Postal Code

02478

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Magnetic Resonance Spectroscopy Studies of Acute Hypoxic and Hyperoxic Breathing in Healthy Volunteers

We'll reach out to this number within 24 hrs