NCT02860975

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

July 30, 2016

Results QC Date

February 17, 2026

Last Update Submit

April 6, 2026

Conditions

Healthy Volunteers

Keywords

Prolonged HypoxiaSafetyMitochondrial function

Outcome Measures

Primary Outcomes (1)

  • Peripheral Oxygen Saturation

    The average of the lowest SpO2 recorded during daytime hours over the 7 days timeframe of the study.

    7 days

Secondary Outcomes (2)

  • Erythropoiesis

    5 days

  • Pulmonary Pressure

    5 days

Study Arms (1)

Inhaled Nitrogen

EXPERIMENTAL

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

Interventions

Inhaled NitrogenOTHER

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.

Inhaled Nitrogen

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have a photo identification (ID)
  • Male or female individuals age between 18 and 40 years old
  • BMI between 19 and 24.9 kg/m2

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02134, United States

Location

Related Links

Results Point of Contact

Title
Dr. Lorenzo Berra
Organization
Massachusetts General Hospital
lberra@mgh.harvard.edu
6177245100

Study Officials

  • Lorenzo Berra, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

July 30, 2016

First Posted

August 10, 2016

Study Start

January 1, 2017

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

April 27, 2026

Results First Posted

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)