UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021155 |
|---|---|
| Receipt number | R000024386 |
| Scientific Title | Development of screening test for acute mountain sickness |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2025/03/09 13:17:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of screening test for acute mountain sickness
Acronym
Development of screening test for acute mountain sickness
Scientific Title
Development of screening test for acute mountain sickness
Scientific Title:Acronym
Development of screening test for acute mountain sickness
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acute mountain sickness (AMS) is triggered by high altitude hypoxia, and can be fatal. Before climbing to high altitude, if we can distinguish who is more likely to suffer from AMS, it should reduce individuals' risk to develop AMS. Nonetheless, few investigators have succeed in predicting AMS at sea level. In order to develop the screening test for AMS, we attempt to elucidate the relationships between cardiorespiratory responses to exercise under various hypoxic conditions and AMS level during actual climbing to high altitude around 3000m.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The optimal methods and parameters for screening test for preventing AMS
Key secondary outcomes
The multiple regression equation of AMS score estimated from various parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_2
Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_3
Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_4
Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_5
Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_6
Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_7
Exercise with Gradual hypoxia and Isocapnea -> Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_8
Exercise with Gradual hypoxia and Isocapnea -> Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_9
Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Interventions/Control_10
Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy middle-aged and elderly adults
those who have climbed high altitude (around or above 3000m) mountains within about two years
Key exclusion criteria
Patients of circulatory or respiratory disease, or those who have limitation of movement (e.g. walking)
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
E5-2(130), Furo-cho, Chikusa-ku, Nagoya 464-8601, JAPAN
TEL
052-788-6258
ishida@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
E5-2(130), Furocho, Chikusaku, Nagoya 464-8601, JAPAN
TEL
052-788-6258
Homepage URL
ishida@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Exercise and Sports Physiology, Nagoya University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Nagoya University Graduate School of Medicine
Address
65, Tsurumai, Showa-ku, Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋大学 総合保健体育科学センター（愛知県）
Research Center of Health, Physical Fitness and Sports, Nagoya University, Aichi, Japan
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
not published
Publication of results
Unpublished
Result
URL related to results and publications
http://www.htc.nagoya-u.ac.jp/~ishida/Personal/Investigation/screeningtest.html
Number of participants that the trial has enrolled
50
Results
The characteristics of those who are more likely to suffer from acute mountain sickness are as follows;
1) Forced vital capacity is lower.
2) Arterial oxygen saturation falls rapidly and below 75% during hypoxic exercise.
3) End tidal partial pressure of CO2 is always higher during rest and exercise.
Results date posted
| 2022 | Year | 02 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because there is a lot of data to analyze.
Date of the first journal publication of results
Baseline Characteristics
Healthy adults
Participant flow
Young healthy participants applied through the university's research participation system. Older healthy participants applied through the local community.
Adverse events
nothing
Outcome measures
SpO2
AMS score
Cardio-respiratory response
Respiratory capacity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
The No. of intervention arms should be 24 arms becuase our experimental conditions are four, the rest arms are as follows;
(Gra=Gradual hypoxia, Acu=Acute hypoxia, Poi=Poikilocapnea, Iso=Isocapnea, Nor=Normoxia)
Arm11: Gra+Iso->Nor+Poi->Gra+Poi->Acu+Poi
Arm12: Gra+Iso->Nor+Poi->Acu+Poi->Gra+Poi
Arm13: Acu+Poi->Gra+Poi->Gra+Iso->Nor+Poi
Arm14: Acu+Poi->Gra+Poi->Nor+Poi->Gra+Iso
Arm15: Acu+Poi->Gra+Iso->Gra+Poi->Nor+Poi
Arm16: Acu+Poi->Gra+Iso->Nor+Poi->Gra+Poi
Arm17: Acu+Poi->Nor+Poi->Gra+Poi->Gra+Iso
Arm18: Acu+Poi->Nor+Poi->Gra+Iso->Gra+Poi
Arm19: Nor+Poi->Gra+Poi->Gra+Iso->Acu+Poi
Arm20: Nor+Poi->Gra+Poi->Acu+Poi->Gra+Iso
Arm21: Nor+Poi->Gra+Iso->Gra+Poi->Acu+Poi
Arm22: Nor+Poi->Gra+Iso->Acu+Poi->Gra+Poi
Arm23: Nor+Poi->Acu+Poi->Gra+Poi->Gra+Iso
Arm24: Nor+Poi->Acu+Poi->Gra+Iso->Gra+Poi
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024386
