Difference in time until onset of symptoms and recovery between hypobaric and normobaric hypoxia

Difference in time until onset of symptoms and recovery between hypobaric and normobaric hypoxia - Hypobaric vs normobaric hypoxia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56865

Enrollment

Registered

2024-07-08

Start date

2024-08-29

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypoxie symptomen en resipiratoire veranderingen bij hypoxieblootstelling bij gezonde deelnemers oxygen deficiency Reduction in blood oxygen saturation

Interventions

Each test subject will undergo a hypobaric hypoxia- and a normobaric hypoxia session

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Aircrew between 18 and 62 years old Previous hypoxia training In possession of an active aeromedical certificate (fit to fly) Willing and able to provide informed consent

Exclusion criteria

Exclusion criteria: Significant adverse event after a previous hypoxia training Ear drum perforation in medical history Claustrophobia Pregnancy Exposure to altitude for longer than one week higher than 8000ft 3 months prior to research Smokers Does not comprehend study requirements and/or is unable to comply with study procedures or pre-session restrictions

Design outcomes

Primary

Measure	Time frame
Difference in time until onset of the first hypoxia symptom and the severity of hypoxia symptoms between Hypobaric Hypoxia (HH) in the hypobaric chamber and Normobaric Hypoxia (NH) in the ROBD at a simulated altitude of 18000 ft. The endpoint is an composite endpoint. At an altitude of 18,000 ft, we expect all test subjects to experience hypoxia symptoms. In the unlikely event that they do not feel their own symptoms. The crossing of their TUC will be considered their first sign of hypoxia. In the unlikely event that test subjects will not experience symptoms and the TUC will not be crossed, censoring will be applied.	—

Measure

Time frame

Difference in time until onset of the first hypoxia symptom and the severity of hypoxia symptoms between Hypobaric Hypoxia (HH) in the hypobaric chamber and Normobaric Hypoxia (NH) in the ROBD at a simulated altitude of 18000 ft. The endpoint is an composite endpoint. At an altitude of 18,000 ft, we expect all test subjects to experience hypoxia symptoms. In the unlikely event that they do not feel their own symptoms. The crossing of their TUC will be considered their first sign of hypoxia. In the unlikely event that test subjects will not experience symptoms and the TUC will not be crossed, censoring will be applied.

—

Secondary

Measure	Time frame
Secondary parameters: I. Difference in time to initiation of recovery (after recognition of the third symptom) between HH and NH. II. Difference in severity of symptoms in HH and NH. III. Difference in respiratory and oxygenation parameters during the different exposures to hypoxia, by measuring the following parameters: a. Oxygen saturation (SpO2) b. Rate of decline of SpO2 c. Respiratory Rate (RR) d. Tidal volume (TV) e. Minute ventilation (Ve) f. Partial pressure of end tidal CO2 (PETCO2) g. Partial pressure of end tidal O2 (PETO2)	—

Measure

Time frame

Secondary parameters: I. Difference in time to initiation of recovery (after recognition of the third symptom) between HH and NH. II. Difference in severity of symptoms in HH and NH. III. Difference in respiratory and oxygenation parameters during the different exposures to hypoxia, by measuring the following parameters: a. Oxygen saturation (SpO2) b. Rate of decline of SpO2 c. Respiratory Rate (RR) d. Tidal volume (TV) e. Minute ventilation (Ve) f. Partial pressure of end tidal CO2 (PETCO2) g. Partial pressure of end tidal O2 (PETO2)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026