Protective Effect of Statin on Sleep Deprivation

Study Overview
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Brief Summary
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This study aimed to investigate the effect of 48-h sleep deprivation on heart rate variability (HRV) in young healthy people and the protective effect of statin on arrhythmia and HRV.

Detailed Description
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In the setting of earthquakes, floods, or fire disasters, rescue workers usually carry out their work without sleep. Sleep deprivation (SD), which is a strong stressor, can exert a large effect on the cardiovascular system of rescue workers. It has been reported that SD is associated with arrhythmia, dyslipidemia and type 2 diabetes. Heart rate variability (HRV) is acknowledged as a reliable marker of cardiac autonomic control, and the frequency of premature ventricular complexes can be an indicator of arrhythmogeneity. The investigators found that HRV was significantly decreased after 24-h sleep deprivation. Metoprolol could improve HRV and reduce the frequency of premature atrial and ventricular complexes. But sleepiness and hypotension occurred frequently in subjects treated with metoprolol. Statins have significant cardiovascular protective effects in patients with cardiovascular disease. Statin not only could regulate serum lipid level, but also have antioxidant and anti-inflammatory properties. This study aimed to investigate (1) the changes in heart rate variability and occurrence of cardiac arrhythmia by continuous ambulatory electrocardiogram (ECG) in young, healthy subjects undergoing 48h SD and (2) the effects of statin on HRV and arrhythmia after this agent was administered prophylactically before SD.

Official Title
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Protective Effect of Statin on Arrhythmia and Heart Rate Variability in Healthy People With 48 Hours of Sleep Deprivation

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subjects without cardiovascular disease Exclusion Criteria: hypertension diabetes mellitus hyperthyroidism taking medication known to affect cardiovascular, metabolic, gastrointestinal, or immune function depression anxiety disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin group<br>drug: atorvastatin (Pfizer, U.S.); the frequency: 20mg atorvastatin was taken daily; duration: Study treatment was commenced 3 days before sleep deprivation and continued for 2 days during sleep deprivation. | Drug: Atorvastatin<br>* atorvastatin were taken daily for 5 days<br>* Other names: Lipitor;|
| Placebo Comparator: Control group<br>drug: placebo (Pfizer, U.S.); the frequency: Placebo was taken daily; duration: Study treatment was commenced 3 days before sleep deprivation and continued for 2 days during sleep deprivation. | Drug: placebo<br>* placebo were taken daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in low-frequency (LF)/ high frequency (HF) | The primary efficacy endpoint was the effect of statin on LF/HF measured by continuous ambulatory electrocardiogram monitoring after 48-h sleep deprivation. | 48-h sleep deprivation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in the frequency of premature atrial and ventricular complexes | The frequency of premature atrial and ventricular complexes during 48-h sleep deprivation were measured by continuous ambulatory electrocardiogram monitoring | 48-h sleep deprivation | 
| a change in serum total cholesterol level | serum total cholesterol level was measured after 48-h sleep deprivation | 48-h sleep deprivation | 
| a change in serum high sensitivity C-reactive protein level | serum high sensitivity C-reactive protein level was measured after 48-h sleep deprivation | 48-h sleep deprivation | 
| a change in serum superoxide dismutase level | serum superoxide dismutase level was measured after 48-h sleep deprivation | 48-h sleep deprivation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep deprivation