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

NCT02600078 | Completed

• 1 other identifier: H15-02093
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

hypoxia; ataxia

Outcome Measures

Primary Outcomes (1)

• Change in score of a coordination test.

  Coordination test will be taken at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.

Secondary Outcomes (4)

• Change in severity of symptoms based on questionnaire.

  Symptoms questionnaire will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.

• Change in score of a balance test.

  Balance test will be taken at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.

• Change in heart rate.

  Heart rate will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.

• Change in pulse oxygen saturation

  Pulse oxygen saturation will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.

Study Arms (3)

Moderate Hypoxia

ACTIVE COMPARATOR

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.

Device: AMS Monitor App; Other: Lake Louise Score; Other: Balance Error Scoring System; Other: Heart Rate & Pulse Oxygen Saturation

Sham

SHAM COMPARATOR

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.

Device: AMS Monitor App; Other: Lake Louise Score; Other: Balance Error Scoring System; Other: Heart Rate & Pulse Oxygen Saturation

Mild Hypoxia

ACTIVE COMPARATOR

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.

Device: AMS Monitor App; Other: Lake Louise Score; Other: Balance Error Scoring System; Other: Heart Rate & Pulse Oxygen Saturation

Interventions

AMS Monitor App DEVICE

Participants will complete a novel coordination task performed on an android phone.

Mild Hypoxia; Moderate Hypoxia; Sham

Lake Louise Score OTHER

Participants will complete a questionnaire to assess acclimatization to hypoxia.

Mild Hypoxia; Moderate Hypoxia; Sham

Balance Error Scoring System OTHER

Participants will complete a series of static stance positions to evaluate their ability to maintain balance.

Mild Hypoxia; Moderate Hypoxia; Sham

Heart Rate & Pulse Oxygen Saturation OTHER

Participants will have their heart rate and pulse oxygen saturation continuously monitored throughout the entire exposure.

Mild Hypoxia; Moderate Hypoxia; Sham

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Sports Medicine Research Foundation: collaborator

Study Sites (1)

Environmental Physiology Laboratory

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Hypoxia; Ataxia

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Michael S Koehle, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters of Science Student

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

CA (1)