HypoxiaHypoxiaNCT01386814
Neuropsychological Sleep Physical Exercise Hypoxia
An observational study of Hypoxia, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2012
- Phase
- Observational
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
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.
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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Aspects of Neuropsychological Assessment, Standard and Sleep Efficiency in People Exposed to Altitude
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
- Conditions
- Hypoxia
- Medical subject headings
- Hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
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.
- 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
- Observational
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marco T Mello, Dr, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386814
- Sponsor's protocol ID
- CEP 1110/08
- Acronym
- Hypoxia
- Status last verified
- May 2009
- First submitted
- 30 Jun 2011
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects of Neuropsychological Assessment, Standard and Sleep Efficiency in People Exposed to Altitude
- ClinicalTrials.gov ID
- NCT01386814
- Acronym / sponsor ID
- Hypoxia / CEP 1110/08
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Jul 2011 (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.
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.
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
Study design
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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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.
Marco T Mello, Dr principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valdir A Lemos, DR (551155720177, aquino.lemos@unifesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 1 Jul 2011.