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

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
AMS Monitor App
Lake Louise Score
Balance Error Scoring System
Heart Rate & Pulse Oxygen Saturation
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxia focused on measuring hypoxia, ataxia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Both Male and Female Gender
  • Minimum Age of 18 years
  • Maximum Age of 45 years
  • Have not traveled to an altitude of 3000m or higher in 3 months prior to testing
  • No history of migraines or concussion
  • Not Smokers
  • Females must be using monophasic birth control
  • Not easily claustrophobic
  • English Speaking

Exclusion Criteria:

  • Non-English speaking individuals
  • Subjects younger than 18 years old or older than 45 years old
  • Subjects who visit an altitude of 3000m or greater within three months prior to the study
  • Subjects with a history of cardiovascular or pulmonary conditions such as; uncontrolled congestive heart failure, COPD, pulmonary hypertension, or sickle cell disease
  • Subjects with a history of migraines or concussion
  • Smokers
  • Females not using monophasic birth control pills
  • Subjects experiencing withdrawal symptoms due to abstinence from caffeine
  • Easily claustrophobic individuals

Sites / Locations

  • Environmental Physiology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Moderate Hypoxia

Sham

Mild Hypoxia

Arm Description

Subjects will be exposed to moderate hypoxia and measures of balance, heart rate, pulse oxygen saturation, questionnaires, and coordination tasks will be examined at set time intervals during the hypoxic exposure.

Subjects will be exposed to sham and measures of balance, heart rate, pulse oxygen saturation, questionnaires, and coordination tasks will be examined at set time intervals during the hypoxic exposure.

Subjects will be exposed to mild hypoxia and measures of balance, heart rate, pulse oxygen saturation, questionnaires, and coordination tasks will be examined at set time intervals during the hypoxic exposure.

Outcomes

Primary Outcome Measures

Change in score of a coordination test.

Secondary Outcome Measures

Change in severity of symptoms based on questionnaire.
Change in score of a balance test.
Change in heart rate.
Change in pulse oxygen saturation

Full Information

First Posted
November 3, 2015
Last Updated
August 26, 2020
Sponsor
University of British Columbia
Collaborators
British Columbia Sports Medicine Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02600078
Brief Title
The Evaluation of a Mobile Device to Measure Ataxia With High Altitude Exposure
Official Title
The Evaluation of a Mobile Device to Measure Ataxia With High Altitude Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
British Columbia Sports Medicine Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
hypoxia, ataxia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Hypoxia
Arm Type
Active Comparator
Arm Description
Subjects will be exposed to moderate hypoxia and measures of balance, heart rate, pulse oxygen saturation, questionnaires, and coordination tasks will be examined at set time intervals during the hypoxic exposure.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Subjects will be exposed to sham and measures of balance, heart rate, pulse oxygen saturation, questionnaires, and coordination tasks will be examined at set time intervals during the hypoxic exposure.
Arm Title
Mild Hypoxia
Arm Type
Active Comparator
Arm Description
Subjects will be exposed to mild hypoxia and measures of balance, heart rate, pulse oxygen saturation, questionnaires, and coordination tasks will be examined at set time intervals during the hypoxic exposure.
Intervention Type
Device
Intervention Name(s)
AMS Monitor App
Intervention Description
Participants will complete a novel coordination task performed on an android phone.
Intervention Type
Other
Intervention Name(s)
Lake Louise Score
Intervention Description
Participants will complete a questionnaire to assess acclimatization to hypoxia.
Intervention Type
Other
Intervention Name(s)
Balance Error Scoring System
Intervention Description
Participants will complete a series of static stance positions to evaluate their ability to maintain balance.
Intervention Type
Other
Intervention Name(s)
Heart Rate & Pulse Oxygen Saturation
Intervention Description
Participants will have their heart rate and pulse oxygen saturation continuously monitored throughout the entire exposure.
Primary Outcome Measure Information:
Title
Change in score of a coordination test.
Time Frame
Coordination test will be taken at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.
Secondary Outcome Measure Information:
Title
Change in severity of symptoms based on questionnaire.
Time Frame
Symptoms questionnaire will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.
Title
Change in score of a balance test.
Time Frame
Balance test will be taken at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.
Title
Change in heart rate.
Time Frame
Heart rate will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.
Title
Change in pulse oxygen saturation
Time Frame
Pulse oxygen saturation will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both Male and Female Gender Minimum Age of 18 years Maximum Age of 45 years Have not traveled to an altitude of 3000m or higher in 3 months prior to testing No history of migraines or concussion Not Smokers Females must be using monophasic birth control Not easily claustrophobic English Speaking Exclusion Criteria: Non-English speaking individuals Subjects younger than 18 years old or older than 45 years old Subjects who visit an altitude of 3000m or greater within three months prior to the study Subjects with a history of cardiovascular or pulmonary conditions such as; uncontrolled congestive heart failure, COPD, pulmonary hypertension, or sickle cell disease Subjects with a history of migraines or concussion Smokers Females not using monophasic birth control pills Subjects experiencing withdrawal symptoms due to abstinence from caffeine Easily claustrophobic individuals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Koehle, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environmental Physiology Laboratory
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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

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