Study Stopped
Could not obtain regulatory approval
Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2025
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2025
CompletedJune 4, 2025
May 1, 2025
5 months
December 1, 2017
May 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I
Elapsed time during which subject's SpO2 remains above 90% after initially reaching or exceeding 94% following exposure to a simulated altitude of 14,000 and after receiving pulse-dosed oxygen
15 minutes
Secondary Outcomes (3)
Amount of oxygen needed to return SpO2 to sea level value I
15 minutes
Amount of oxygen needed to return SpO2 to sea level value II
15 minutes
Elapsed time during which SpO2 remains above 90% II
15 minutes
Eligibility Criteria
Normal volunteers aged 18 to 65 years, inclusive
You may qualify if:
- Altitude chamber qualified
- Previous agreement to be approached regarding altitude chamber research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
December 1, 2017
First Posted
December 7, 2017
Study Start
January 1, 2025
Primary Completion
May 28, 2025
Study Completion
May 28, 2025
Last Updated
June 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share