Effects of Hypoxia on Cognitive Performance

NCT06318312 | Completed

• 1 other identifier: HYP_MR_2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Hypoxia

Keywords

cognitive; anticipation; memory; attention; reaction time

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (4)

11% FiO2

EXPERIMENTAL

Hypoxic exposure: fraction of oxygen inspired (FiO2) = 11% (\~5100 m, \~16735 ft)

Other: Hypoxia

13% FiO2

EXPERIMENTAL

Hypoxic exposure: fraction of oxygen inspired (FiO2) = 13% (\~3800 m, \~12470 ft)

Other: Hypoxia

15% FiO2

EXPERIMENTAL

Hypoxic exposure: fraction of oxygen inspired (FiO2) = 15% (\~2750 m, \~9000 ft)

Other: Hypoxia

PLA / 21% FiO2

PLACEBO COMPARATOR

Hypoxic exposure / placebo condition: fraction of oxygen inspired (FiO2) = 21% (sea level)

Other: Hypoxia

Interventions

Hypoxia OTHER

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

Also known as: hypoxic exposure

11% FiO2; 13% FiO2; 15% FiO2; PLA / 21% FiO2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Performance and Sport Rehabilitation Laobratory. University of Castilla-La Mancha

Toledo, 45004, Spain

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 20, 2024
• Primary Completion: April 5, 2024
• Study Completion: April 26, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)