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Status unknownNCT01386814HypoxiaUpdated Jul 1, 2011

Neuropsychological Sleep Physical Exercise Hypoxia

An observational study in Hypoxia, sponsored by Federal University of São Paulo. Status unknown. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-01.

Sponsored by Federal University of São Paulo · Observational

The sponsor has not verified this record recently (last verified May 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Enrollment
60
Ages
20 Years to 40 Years
Sex
Male
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Study summary

Aim: To evaluate the influence of oxygen deficit on the cognitive performance and also about the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise in a hypobaric chamber. SUMMARY: Participants in this study 30 healthy male volunteers, aged 20 to 40 years, regular physical activity, constituting three groups: 1 - without exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10 volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same in condition of hypoxia (hypobaric chamber). All groups on the first day of the experiment will undergo baseline assessments, laboratory blood analysis salivary and spirometric testing. Assessments will be personality and neuropsychological. After baseline assessments, the last day of the experiment, the groups will be evaluated again 4350m above sea level the sea, by personality tests, neuropsychological and laboratory. RATIONALE AND BACKGROUND: During exposure to environments with a partial reduction of oxygen, human body can undergo several physiological and psychological changes are not prepared for such condition. Few studies have reported that the elevation changes and cognitive aspects related to sleep.

MATERIAL AND METHOD: They describe the procedures to be performed, and the study conducted in local with adequate infrastructure.

Read the detailed description

ADDITIONAL RISKS TO THE PATIENT: Minimal risk, mild discomfort, involving blood collect. Purpose: To evaluate the influence of oxygen deficit on the cognitive performance and also about the architecture and sleep efficiency in volunteers subjected to mild and moderate exercise in a hypobaric chamber.

SUMMARY: Participants in this study 30 healthy male volunteers, aged 20 to 40 years, regular physical activity, constituting three groups: 1 - without exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10 volunteers who will undergo a protocol exercise physical sea-level, 3 - group exercise and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same in condition of hypoxia (hypobaric chamber). All groups on the first day of the experiment will undergo baseline assessments, laboratory blood analysis salivary and spirometric testing. Assessments will be personality and neuropsychological. After baseline assessments, the last day of the experiment, the groups will be evaluated again 4350m above sea level the sea, by personality tests, neuropsychological and laboratory. RATIONALE AND BACKGROUND: During exposure to environments with a partial reduction of oxygen, human body can undergo several physiological and psychological changes are not prepared for such condition. Few studies have reported that the elevation changes and cognitive aspects related to sleep

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Conditions studied

  • Hypoxia

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Participants in this study 30 healthy male volunteers, aged 20 to 40 years, regular physical activity, constituting three groups: 1 - without exercise-hypoxia group 10 volunteers who not be subjected to any kind of physical exercise in hypoxia and remain all day of experiment, 2 - group exercise at sea level, is composed of 10 volunteers who will undergo a protocol exercicio physical sea-level, 3 - group exercise and hypoxia - 10 volunteers who will carry out a protocol exercise on a treadmill, being the same in condition of hypoxia. All groups on the first day of the experiment will undergo baseline assessments, laboratory blood analysis salivary and spirometric testing.

Eligibility criteria

Inclusion Criteria:Be physically active (perform aerobic exercise at least three times a week for at least 1 year);

  • Minimum age 12 years school;
  • Intelligence quotient ≥ 80.

Exclusion Criteria:Present health problems (as assessed by cardiac and respiratory care) and those that do not allow the practice of exercise;

  • Present changes in resting electrocardiogram and effort and in clinical evaluation conducted by the Medical Center for Psychobiology and Exercise;
  • Being a smoker and / or using drugs of abuse;
  • Make use of psychotropic medications;
  • Make use of alcoholic beverages frequently;
  • Display sleep disorders
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Study design

Enrollment
60 participants (estimated)
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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01386814
Lead sponsor
Federal University of São Paulo
First posted
Jul 1, 2011
Start date
Jul 2011
Primary completion
Jun 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jul 1, 2011

Study contacts

Valdir A Lemos, DR
Contact
aquino.lemos@unifesp.br
551155720177
Marco T Mello, Dr
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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