HypoxiaNCT02600078
The Evaluation of a Mobile Device to Measure Ataxia With High Altitude Exposure
A study testing AMS Monitor App, Lake Louise Score and Balance Error Scoring System in people with Hypoxia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- AMS Monitor App, Lake Louise Score and Balance Error Scoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Females must be using monophasic birth control
- Not easily claustrophobic
- English Speaking
Who cannot join
- 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
Show all 9Show fewer
- Females not using monophasic birth control pills
- Subjects experiencing withdrawal symptoms due to abstinence from caffeine
- Easily claustrophobic individuals
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- AMS Monitor App, Lake Louise Score, Balance Error Scoring System, Heart Rate & Pulse Oxygen Saturation
- Keywords
- hypoxia, ataxia
- Medical subject headings
- Hypoxia, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMS Monitor AppDevice
Participants will complete a novel coordination task performed on an android phone.
Lake Louise ScoreOther
Participants will complete a questionnaire to assess acclimatization to hypoxia.
Balance Error Scoring SystemOther
Participants will complete a series of static stance positions to evaluate their ability to maintain balance.
Heart Rate & Pulse Oxygen SaturationOther
Participants will have their heart rate and pulse oxygen saturation continuously monitored throughout the entire exposure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: AMS Monitor App; Other: Lake Louise Score; Other: Balance Error Scoring System; Other: Heart Rate & Pulse Oxygen Saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score of a coordination test.
Measured: 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.
Measured: 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.
Measured: Balance test will be taken at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.
Change in heart rate.
Measured: 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
Measured: Pulse oxygen saturation will be assessed at baseline and at 5 minutes, 4 and 12 hours into a simulated altitude exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Sports Medicine Research Foundation
- Responsible party
- Principal investigator, Elliott Boake, University of British Columbia
- Investigators
- Michael S Koehle, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600078
- Sponsor's protocol ID
- H15-02093
- Status last verified
- Aug 2020
- First submitted
- 3 Nov 2015
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Mobile Device to Measure Ataxia With High Altitude Exposure
- ClinicalTrials.gov ID
- NCT02600078
- Acronym / sponsor ID
- H15-02093
- Conditions
- Hypoxia
- Keywords
- hypoxia, ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Sports Medicine Research Foundation
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Hypoxia | Active comparator | Device: AMS Monitor App, Other: Lake Louise Score, Other: Balance Error Scoring System, Other: Heart Rate & Pulse Oxygen SaturationSubjects 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. |
| Sham | Sham comparator | Device: AMS Monitor App, Other: Lake Louise Score, Other: Balance Error Scoring System, Other: Heart Rate & Pulse Oxygen SaturationSubjects 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. |
| Mild Hypoxia | Active comparator | Device: AMS Monitor App, Other: Lake Louise Score, Other: Balance Error Scoring System, Other: Heart Rate & Pulse Oxygen SaturationSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMS Monitor AppParticipants will complete a novel coordination task performed on an android phone. | Device | Mild Hypoxia, Moderate Hypoxia, Sham |
| Lake Louise ScoreParticipants will complete a questionnaire to assess acclimatization to hypoxia. | Other | Mild Hypoxia, Moderate Hypoxia, Sham |
| Balance Error Scoring SystemParticipants will complete a series of static stance positions to evaluate their ability to maintain balance. | Other | Mild Hypoxia, Moderate Hypoxia, Sham |
| Heart Rate & Pulse Oxygen SaturationParticipants will have their heart rate and pulse oxygen saturation continuously monitored throughout the entire exposure. | Other | Mild Hypoxia, Moderate Hypoxia, Sham |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Koehle, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMS Monitor App, Lake Louise Score and Balance Error Scoring System in people with Hypoxia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.