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Trial record 2 of 69 for:    "Sleep Deprivation"
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Cardiovascular Effects of Partial Sleep Deprivation

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00669513
First received: April 28, 2008
Last updated: April 29, 2008
Last verified: April 2008
History of Changes
  Purpose

Background: Sleep curtailment is common and is associated with increased mortality due to cardiovascular causes. However, the mechanisms are not completely understood.We hypothesized that partial sleep deprivation caused however significant changes in sympathetic activity and endothelial function in healthy volunteers.

Methods: Thirteen young healthy male volunteers will be monitored during 12 days by sleep diary and wrist actigraphy. The subjects will keep under their usual daily activities and randomized to 5 nights of prolonged sleep (control) or partial sleep deprivation, interposed by 2 nights of unrestricted sleep (wash out). At the end of each period, the subjects will be evaluate by: 1. electrocardiogram and beat-to-beat blood pressure with spectral analysis of heart rate and blood pressure in the supine position and after head up tilt test maneuver; 2. resting plasma norepinephrine; 3. venous endothelial function (dorsal hand vein technique).


Condition Intervention Phase
Sleep Deprivation
 Behavioral: Partial sleep deprivation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Cardiovascular Effects of Partial Sleep Deprivation in Healthy Volunteers

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Venous endothelial function

Secondary Outcome Measures:
  • Sympathetic activity
  • Inflammation

Enrollment: 15
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
Partial sleep deprivation
 Behavioral: Partial sleep deprivation
Partial sleep deprivation (less than 5 hours, but no less than 3 hours and 30 minutes)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy young male volunteers from the urban area of Sao Paulo city

Exclusion Criteria:

  • Age less than 21 and more than 45 years
  • Body mass index (BMI) >25 kg/m2
  • Smoking

  • Use of chronic medications and any established medical condition including

    • diabetes mellitus
    • hypertension
    • dyslipidemia
    • heart diseases and
    • sleep disordered breathing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669513

Locations
Brazil
Heart Institute (InCor)
Sao Paulo, Brazil, 05403-904
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Josilene L Dettoni, PhD Heart Institute (InCor)
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00669513     History of Changes
Other Study ID Numbers: PSP-CV
Study First Received: April 28, 2008
Last Updated: April 29, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
partial sleep deprivation
endothelial dysfunction
sympathetic activity
inflammation

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013