NCT03365128

Brief Summary

This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
withdrawn

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

December 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
7.1 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

December 1, 2017

Last Update Submit

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

0

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