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

NCT03106376 | Withdrawn

• 1 other identifier: 2017P000328
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• NAD+/NADH ratio

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

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

Secondary Outcomes (4)

• CK Kf

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

• PCr

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

• Pi

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

• ATP

  During 30 minute hypoxic/hyperoxic exposure portion of theMRS scan

Study Arms (1)

Healthy subjects

EXPERIMENTAL

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

Other: 16% O2 gas in breathed air; Other: 26% O2 gas in breathed air

Interventions

16% O2 gas in breathed air OTHER

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.

Healthy subjects

26% O2 gas in breathed air OTHER

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.

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Study Officials

• Dost Ongur, MD PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 10, 2017
• Study Start: August 29, 2023
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)