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Neuropsychological Sleep Physical Exercise Hypoxia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Federal University of São Paulo.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01386814
First received: June 30, 2011
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition
Hypoxia

Study Type: Observational
Official Title: Aspects of Neuropsychological Assessment, Standard and Sleep Efficiency in People Exposed to Altitude

Further study details as provided by Federal University of São Paulo:

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386814

Contacts
Contact: Valdir A Lemos, DR 551155720177 aquino.lemos@unifesp.br

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Marco T Mello, Dr Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Marco Túlio de Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01386814     History of Changes
Other Study ID Numbers: CEP 1110/08
Study First Received: June 30, 2011
Last Updated: June 30, 2011
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on November 25, 2014