Trial Outcomes & Findings for Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study (NCT NCT02860975)
NCT ID: NCT02860975
Last Updated: 2026-04-27
Results Overview
The average of the lowest SpO2 recorded during daytime hours over the 7 days timeframe of the study.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
7 days
Results posted on
2026-04-27
Participant Flow
Participant milestones
| Measure |
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.
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study
Baseline characteristics by cohort
| Measure |
Inhaled Nitrogen
n=5 Participants
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.
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.
|
|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=226 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=226 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=226 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=226 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=226 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=226 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=226 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=226 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=226 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=226 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=226 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=226 Participants
|
|
BMI
|
26.2 kg/m^2
STANDARD_DEVIATION 2.2 • n=226 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe average of the lowest SpO2 recorded during daytime hours over the 7 days timeframe of the study.
Outcome measures
| Measure |
Inhaled Nitrogen
n=5 Participants
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.
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.
|
|---|---|
|
Peripheral Oxygen Saturation
|
81.4 percentage of SpO2
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 5 daysThe average of erythropoietin levels over 5 days of hypoxia exposure.
Outcome measures
| Measure |
Inhaled Nitrogen
n=5 Participants
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.
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.
|
|---|---|
|
Erythropoiesis
|
18.7 mu/ml
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 5 daysThe average of the highest pulmonary pressure over the 5 days of hypoxia exposure.
Outcome measures
| Measure |
Inhaled Nitrogen
n=5 Participants
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.
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.
|
|---|---|
|
Pulmonary Pressure
|
34.2 mmHg
Standard Deviation 3.6
|
Adverse Events
Inhaled Nitrogen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place