Protective Effect of Statin on Sleep Deprivation

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496962
• Other study ID #: S2015-091-01
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2015
• Last updated: July 10, 2015
• Start date: July 2015

Study information

• Verified date: July 2015
• Source: Chinese PLA General Hospital
• Contact: yang shi, M.D.
• Phone: +8610-66876231
• Email: 301shiy[@]sina.cn
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Drug:
• Atorvastatin
atorvastatin were taken daily for 5 days
• placebo
placebo were taken daily for 5 days

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shi Yang

Country where clinical trial is conducted

China, 

References & Publications (4)

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/s10 — View 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. Review. — View Citation

Kumagai K. [Upstream therapy for atrial fibrillation]. Nihon Rinsho. 2013 Jan;71(1):86-90. Review. Japanese. — View Citation

Rööst M, Nilsson P. [Sleep disorders--a public health problem. Potential risk factor in the development of type 2 diabetes, hypertension, dyslipidemia and premature aging]. Lakartidningen. 2002 Jan 17;99(3):154-7. Review. Swedish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	a composite outcome (the incidences of treatment-emergent adverse events)	Treatment-emergent adverse events (TEAEs): abnormal liver function, renal insufficiency and constipation	48-h sleep deprivation	Yes
Primary	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	No
Secondary	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	No
Secondary	a change in serum total cholesterol level	serum total cholesterol level was measured after 48-h sleep deprivation	48-h sleep deprivation	No
Secondary	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	No
Secondary	a change in serum superoxide dismutase level	serum superoxide dismutase level was measured after 48-h sleep deprivation	48-h sleep deprivation	No