NCT00326703

Brief Summary

Commercial aircraft passengers are exposed to atmospheric pressures ranging from the pressure found at ground level to that encountered in the external environment at 8,000 feet. There is some evidence in the medical literature that symptoms of acute mountain sickness can result from ascent to altitudes of 6,300 to 10,000 feet by unacclimated persons during the first few days following ascent, probably due to the hypoxia that results from breathing air at the reduced ambient pressures at altitude. The logical hypothesis that follows is that exposure to 8,000 feet could cause hypoxia sufficient to adversely affect the comfort and well being of some commercial aircraft passengers on prolonged flights. There is insufficient data in the literature to validate this hypothesis. Exercise at sea level and at altitude reduces arterial oxygen levels. The logical hypothesis that follows is that the combination of moderate exercise and exposure to altitude could cause hypoxia sufficiently severe to adversely affect the comfort and well being of some people and that the combined effect of exercise and altitude on comfort and well being is greater than the effect of exercise or altitude alone. Again, there is insufficient evidence in the literature to substantiate this possibility. The purpose of this investigation is to test these hypotheses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

October 1, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
Last Updated

October 17, 2006

Status Verified

May 1, 2006

First QC Date

May 15, 2006

Last Update Submit

October 16, 2006

Conditions

Keywords

hypoxiahypobaricaltitude

Outcome Measures

Primary Outcomes (2)

  • ESQ IV factor scores measured at 2 hour intervals

  • Oxygen Saturation measured at 2 hour intervals

Interventions

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Muhm JM, Rock PB, McMullin DL, Jones SP, Lu IL, Eilers KD, Space DR, McMullen A. Effect of aircraft-cabin altitude on passenger discomfort. N Engl J Med. 2007 Jul 5;357(1):18-27. doi: 10.1056/NEJMoa062770.

MeSH Terms

Conditions

Altitude SicknessHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James M Muhm, MD, MPH

    The Boeing Company

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

October 1, 2002

Study Completion

April 1, 2003

Last Updated

October 17, 2006

Record last verified: 2006-05