Cardiovascular Effects of Partial Sleep Deprivation - Full Text View

Sponsor:	University of Sao Paulo
Collaborators:	Fundação de Amparo à Pesquisa do Estado de São Paulo CNPq
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00669513

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 III

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment
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
1: No Intervention
2: Experimental Partial sleep deprivation	Behavioral: Partial sleep deprivation Partial sleep deprivation (less than 5 hours, but no less than 3 hours and 30 minutes)

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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

CNPq

Investigators

Principal Investigator:

Josilene L Dettoni, PhD

Heart Institute (InCor)

More Information

No publications provided

Study ID Numbers:	PSP-CV
Study First Received:	April 28, 2008
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00669513 History of Changes
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:

Signs and Symptoms
Mental Disorders
Nervous System Diseases
Neurologic Manifestations

Sleep Disorders
Dyssomnias
Sleep Deprivation

ClinicalTrials.gov processed this record on November 27, 2009