NCT02600078

The Evaluation of a Mobile Device to Measure Ataxia With High Altitude Exposure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

With exposure to high altitude some individuals will develop acute mountain sickness (AMS). Current evaluation of AMS can make it difficult to rule out other possible conditions. Evaluation of ataxia, as measured by the performance of a coordinated task, can aide in the correct diagnosis of AMS. The investigators have developed novel finger-tapping tasks on a mobile device to assess both reaction time and accuracy. The proposed research will evaluate the utility of this tool in assessing human acclimatization to hypoxia.

Detailed description

Introduction: Hypoxia is the reduction in partial pressure of oxygen that occurs with exposure to altitude. Individuals acclimatize at different rates and to different degrees meaning that those who are slow to make the necessary physiological adjustments will develop signs and symptoms of acute mountain sickness (AMS). AMS is marked by headache, gastrointestinal disturbances, insomnia, fatigue and ataxia, which can be evaluated using subjective questionnaires such as the Lake Louise Score (LLS). Evaluation of AMS by solely using subjective questionnaires can make differential diagnosis of other possible pathologies difficult. Ataxia is characterized by poor coordination in the absence of significant weakness. Ataxia can be assessed with the performance of a coordinated task. The investigators have developed a novel finger-tapping task on a mobile device to assess both reaction time and accuracy. The proposed research will evaluate the utility of this tool in assessing human acclimatization to hypoxia, which could ultimately serve as a novel, objective methodology in the diagnosis of AMS. Hypothesis: (1) When exposed to simulated altitude (equivalent to 4200m above sea level), subjects will exhibit diminished coordination relative to a sham exposure. (2) Reaction time of novel coordination tasks will positively correlate with heart rate, balance, and LLS. (3) Accuracy of novel coordination tasks will negatively correlate with heart rate, balance, and LLS. Methods: A repeated-measures design with a familiarization trial, a hypoxic trial, and a sham trial will be used. Sixteen healthy adults will be exposed to normobaric hypoxia in the investigator's chamber, simulating an elevation of 4200m above sea level. Subjects will be measured for pulse oxygen saturation, heart rate, and will complete the LLS, the Balance Error Scoring System (BESS), as well as two electronic finger tap coordination tasks prior to, and at 5 minutes, 4, and 12 hours into the altitude chamber exposure. Outcomes: This research will enhance the investigators understanding of the relationship between coordination, balance, and acclimatization to hypoxia. It will allow us to validate a new objective tool in the measurement of acclimatization with exposure to hypoxia.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	AMS Monitor App	Participants will complete a novel coordination task performed on an android phone.
OTHER	Lake Louise Score	Participants will complete a questionnaire to assess acclimatization to hypoxia.
OTHER	Balance Error Scoring System	Participants will complete a series of static stance positions to evaluate their ability to maintain balance.
OTHER	Heart Rate & Pulse Oxygen Saturation	Participants will have their heart rate and pulse oxygen saturation continuously monitored throughout the entire exposure.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-03-01
• Completion: 2016-12-01
• First posted: 2015-11-09
• Last updated: 2020-08-28

Locations

1 site across 1 country: Canada