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Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study (MGH-nitrogen)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860975
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Rezoagli, Emanuele, M.D., Massachusetts General Hospital, Harvard Medical School
Ferrari, Michele, M.D., Massachusetts General Hospital, Harvard Medical School
Patel, Sarvagna, B.A., Massachusetts General Hospital, Harvard Medical School
Zapol, Warren M., M.D., Massachusetts General Hospital, Harvard Medical School
Fisher, Daniel, R.R.T., Massachusetts General Hospital, Harvard Medical School
Jain, Isha, B.A., Massachusetts General Hospital, Harvard Medical School
Mootha, Vamsi, M.D., Massachusetts General Hospital, Harvard Medical School
Harris, Stuart N., M.D., Massachusetts General Hospital, Harvard Medical School
Karaa, Amel, M.D., Massachusetts General Hospital, Harvard Medical School
Information provided by (Responsible Party):
Lorenzo Berra, MD, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to define the safety and the biochemical-physiological response of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Inhaled Nitrogen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiological and Biochemical Response to Prolonged Exposure to Hypoxic Breathing in Healthy Volunteers
Actual Study Start Date : January 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Inhaled Nitrogen
A humidified mixture of gas will be delivered by mask, nasal cannulae, and small room-sized tent. Inspiratory oxygen fraction (FiO2) will be gradually decreased to 11% over a period or five days to obtain a peripheral capillary O2 saturation (SpO2) between 80%-85% (corresponding to 40-55 mmHg of arterial partial oxygen pressure (PaO2)). Healthy volunteers will be monitored and blood and urine will be obtained at 24h and 48 hours after returning to normoxia.
Other: Inhaled Nitrogen

To create the correct gas mixture, nitrogen tanks or membrane technology nitrogen generators will be utilized.

Humidified, high flow, hypoxic gas by nasal cannula will allow the participant to walk short distances, eat, execute basic personal needs (e.g., use of toilette, washing, bathing etc.), or take breaks from wearing the mask.





Primary Outcome Measures :
  1. Peripheral oxygen saturation [ Time Frame: 7 days ]
    Peripheral oxygen saturation of the healthy volunteers receiving different levels of FiO2 will be continuously monitored for the 5 days of hypoxia titration and the 2 days after return to normoxia.


Secondary Outcome Measures :
  1. Erythropoiesis [ Time Frame: 7 days ]
    Erythropoietin will be tested each day during the 7 day study period.

  2. Pulmonary pressure [ Time Frame: 7 days ]
    Pulmonary pressure will be non-invasively measured via transthoracic echocardiography each day during the 7 day study period.

  3. Mitochondrial oxidative stress [ Time Frame: 7 days ]
    Plasma reactive oxygen species (ROS) will be evaluated each day during the 7 day study period.

  4. Acid-base status [ Time Frame: 7 days ]
    Venous acid-base status will be evaluated each day during the 7 day study period.

  5. Systemic blood pressure [ Time Frame: 7 days ]
    Systemic blood pressure will be regularly monitored during the 7 day study period.

  6. Heart rate [ Time Frame: 7 days ]
    Heart rate will be continuously monitored via electrocardiography (EKG) during the 7 day study period.

  7. Respiratory rate [ Time Frame: 7 days ]
    Respiratory rate will be regularly monitored during the 7 day study period.

  8. Anaerobiotic glycolytic pathway [ Time Frame: 7 days ]
    Lactate levels will be tested each day during the 7 day study period.

  9. Energy metabolism [ Time Frame: 7 days ]
    Alpha-hydroxybutyrate levels will be tested each day during the 7 day study period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Have a photo identification (ID)
  • Male or female individuals age between 18 and 40 years old
  • BMI between 19 and 24.9 kg/m2
  • Having capacity to consent to the study Exclusion criteria
  • Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous
  • 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
  • Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), or less than six weeks postpartum
  • Women who are not willing to receive urine pregnancy tests
  • Active smoking. 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
  • Tobacco chewers
  • Abnormal hemoglobin or hematocrit levels or presence of hemoglobin S
  • Evidence of apnea or other sleeping disorders
  • Evidence of asthma
  • Lower respiratory infection within the last 30 days
  • If applicable, unwilling to refrain from using energy drinks or other caffeinated beverages for 7 days prior to and during the study
  • If applicable, unwilling to refrain from use of all over-the-counter oral medications, herbal remedies, and nutritional supplements for 7 days prior to and during the study
  • Not willing to have blood drawn from an arm vein each test day of the study
  • Claustrophobia (inability to wear a facemask) or other active psychiatric conditions or not willingness to cooperate with the investigators and the other medical team
  • Currently enrolled in another research study
  • Facial abnormalities that would preclude proper use of a face mask

Pregnancy Prevention/Testing: Women using oral, subdermal or injectable contraceptives, and those using other means of birth control may participate. A urine pregnancy test will be conducted as part of the screening process for study participation no more than 7 days before starting the study. The test result will be read by a female staff member who will keep the result confidential. If a woman declines to have a pregnancy test, she will not be able to participate.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860975


Contacts
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Contact: Lorenzo Berra, MD 617-724-7901 lberra@mgh.harvard.edu
Contact: Warren Myron Zapol, MD 617-643-4349 WZAPOL@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02134
Contact: Lorenzo Berra, MD    617-643-7733    lberra@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Rezoagli, Emanuele, M.D., Massachusetts General Hospital, Harvard Medical School
Ferrari, Michele, M.D., Massachusetts General Hospital, Harvard Medical School
Patel, Sarvagna, B.A., Massachusetts General Hospital, Harvard Medical School
Zapol, Warren M., M.D., Massachusetts General Hospital, Harvard Medical School
Fisher, Daniel, R.R.T., Massachusetts General Hospital, Harvard Medical School
Jain, Isha, B.A., Massachusetts General Hospital, Harvard Medical School
Mootha, Vamsi, M.D., Massachusetts General Hospital, Harvard Medical School
Harris, Stuart N., M.D., Massachusetts General Hospital, Harvard Medical School
Karaa, Amel, M.D., Massachusetts General Hospital, Harvard Medical School
Investigators
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Principal Investigator: Lorenzo Berra, MD Massachusetts General Hospital
Additional Information:
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Responsible Party: Lorenzo Berra, MD, Assistant Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02860975    
Other Study ID Numbers: MGH-ACCCR
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorenzo Berra, MD, Massachusetts General Hospital:
Prolonged Hypoxia
Safety
Mitochondrial function
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes