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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06318312
Other study ID # HYP_MR_2024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2024
Est. completion date April 26, 2024

Study information

Verified date March 2024
Source University of Castilla-La Mancha
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are: - What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks? - Which hypoxia exposure causes the greatest detriments in cognitive function?


Description:

Participants will completed four trials in a single-blinded crossover randomised control trial. In the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. In the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. The vital signs (i.e., SpO2, HR, blood pressure) and Lake Louise Score were recorded prior to mask placed and start with in one of the four conditions: a) PLA/NOR, b) FiO2=15%, c) FiO2=13% or FiO2=11%. In this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date April 26, 2024
Est. primary completion date April 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Physically active individuals ( >150 min/week moderate physical activity or >75 min/week vigorous physical activity) - Non-smokers - Individuals without serious and undiagnosed health problems Exclusion Criteria: - Pregnancy and/or breastfeeding - Residing at an altitude of more than 1300 m - Having been exposed to an altitude of more than 900 m in the last 8 months - Having performed a study with hypoxia in the last 8 months - Suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hypoxia
Hypoxic exposure: FiO2 = 11% Hypoxic exposure: FiO2 = 13% Hypoxic exposure: FiO2 = 15% Hypoxic exposure / placebo: FiO2 = 21%

Locations

Country Name City State
Spain Performance and Sport Rehabilitation Laobratory. University of Castilla-La Mancha Toledo

Sponsors (1)

Lead Sponsor Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Memory To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time. During each hypoxic condition
Primary Attention The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and "Eriksen Flanker Test" [congruent and incongruent reaction time (in seconds)]. During each hypoxic condition
Primary Anticipation Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken. During each hypoxic condition
Primary Reaction time Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured. During each hypoxic condition
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