Clinical trial NCT02496962: Protective Effect of Statin on Sleep Deprivation
Official title: Protective Effect of Statin on Arrhythmia and Heart Rate Variability in Healthy People With 48 Hours of Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Deprivation
Keywords: sleep deprivation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: a change in low-frequency (LF)/ high frequency (HF)
timeFrame: 48-h sleep deprivation
Secondary outcomes:
measure: a change in the frequency of premature atrial and ventricular complexes
timeFrame: 48-h sleep deprivation
measure: a change in serum total cholesterol level
timeFrame: 48-h sleep deprivation
measure: a change in serum high sensitivity C-reactive protein level
timeFrame: 48-h sleep deprivation
measure: a change in serum superoxide dismutase level
timeFrame: 48-h sleep deprivation
Other outcomes:
measure: a composite outcome (the incidences of treatment-emergent adverse events)
timeFrame: 48-h sleep deprivation
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
References:
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citation: Kumagai K. [Upstream therapy for atrial fibrillation]. Nihon Rinsho. 2013 Jan;71(1):86-90. Japanese.
citation: Jacob KA, Nathoe HM, Dieleman JM, van Osch D, Kluin J, van Dijk D. Inflammation in new-onset atrial fibrillation after cardiac surgery: a systematic review. Eur J Clin Invest. 2014 Apr;44(4):402-28. doi: 10.1111/eci.12237. Epub 2014 Jan 30.
citation: Chen WR, Shi XM, Yang TS, Zhao LC, Gao LG. Protective effect of metoprolol on arrhythmia and heart rate variability in healthy people with 24 hours of sleep deprivation. J Interv Card Electrophysiol. 2013 Apr;36(3):267-72; discussion 272. doi: 10.1007/s10840-012-9728-8. Epub 2012 Nov 20.
citation: Chen WR, Liu HB, Sha Y, Shi Y, Wang H, Yin DW, Chen YD, Shi XM. Effects of Statin on Arrhythmia and Heart Rate Variability in Healthy Persons With 48-Hour Sleep Deprivation. J Am Heart Assoc. 2016 Oct 31;5(11):e003833. doi: 10.1161/JAHA.116.003833.