Neuropsychological Sleep Physical Exercise Hypoxia

NCT01386814 | Unknown DMC

• 1 other identifier: CEP 1110/08
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypoxia

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Marco T Mello, Dr

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valdir A Lemos, DR

CONTACT

551155720177; aquino.lemos@unifesp.br

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 1, 2011

Record last verified: 2009-05