Cardiovascular Effects of Partial Sleep Deprivation
1 other identifier
interventional
15
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 30, 2008
CompletedApril 30, 2008
April 1, 2008
2 years
April 28, 2008
April 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Venous endothelial function
Secondary Outcomes (2)
Sympathetic activity
Inflammation
Study Arms (2)
1
NO INTERVENTION2
EXPERIMENTALPartial sleep deprivation
Interventions
Partial sleep deprivation (less than 5 hours, but no less than 3 hours and 30 minutes)
Eligibility Criteria
You may qualify if:
- Healthy young male volunteers from the urban area of Sao Paulo city
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute (InCor)
São Paulo, São Paulo, 05403-904, Brazil
Related Publications (1)
Dettoni JL, Consolim-Colombo FM, Drager LF, Rubira MC, Souza SB, Irigoyen MC, Mostarda C, Borile S, Krieger EM, Moreno H Jr, Lorenzi-Filho G. Cardiovascular effects of partial sleep deprivation in healthy volunteers. J Appl Physiol (1985). 2012 Jul;113(2):232-6. doi: 10.1152/japplphysiol.01604.2011. Epub 2012 Apr 26.
PMID: 22539169DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josilene L Dettoni, PhD
Heart Institute (InCor)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2008
First Posted
April 30, 2008
Study Start
January 1, 2006
Primary Completion
January 1, 2008
Study Completion
April 1, 2008
Last Updated
April 30, 2008
Record last verified: 2008-04