Protective Effect of Statin on Sleep Deprivation
Primary Purpose
Sleep Deprivation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation focused on measuring sleep deprivation
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
Sites / Locations
- PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Statin group
Control group
Arm Description
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: 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
a change in serum total cholesterol level
serum total cholesterol level was measured after 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
a change in serum superoxide dismutase level
serum superoxide dismutase level was measured after 48-h sleep deprivation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02496962
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shi Yang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep deprivation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Statin group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
atorvastatin were taken daily for 5 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo were taken daily for 5 days
Primary Outcome Measure Information:
Title
a change in low-frequency (LF)/ high frequency (HF)
Description
The primary efficacy endpoint was the effect of statin on LF/HF measured by continuous ambulatory electrocardiogram monitoring after 48-h sleep deprivation.
Time Frame
48-h sleep deprivation
Secondary Outcome Measure Information:
Title
a change in the frequency of premature atrial and ventricular complexes
Description
The frequency of premature atrial and ventricular complexes during 48-h sleep deprivation were measured by continuous ambulatory electrocardiogram monitoring
Time Frame
48-h sleep deprivation
Title
a change in serum total cholesterol level
Description
serum total cholesterol level was measured after 48-h sleep deprivation
Time Frame
48-h sleep deprivation
Title
a change in serum high sensitivity C-reactive protein level
Description
serum high sensitivity C-reactive protein level was measured after 48-h sleep deprivation
Time Frame
48-h sleep deprivation
Title
a change in serum superoxide dismutase level
Description
serum superoxide dismutase level was measured after 48-h sleep deprivation
Time Frame
48-h sleep deprivation
Other Pre-specified Outcome Measures:
Title
a composite outcome (the incidences of treatment-emergent adverse events)
Description
Treatment-emergent adverse events (TEAEs): abnormal liver function, renal insufficiency and constipation
Time Frame
48-h sleep deprivation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yang shi, M.D.
Phone
+8610-66876231
Email
301shiy@sina.cn
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
11838069
Citation
Roost 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. Swedish.
Results Reference
background
PubMed Identifier
23631177
Citation
Kumagai K. [Upstream therapy for atrial fibrillation]. Nihon Rinsho. 2013 Jan;71(1):86-90. Japanese.
Results Reference
background
PubMed Identifier
24387767
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.
Results Reference
background
PubMed Identifier
23179915
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.
Results Reference
result
PubMed Identifier
27799236
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.
Results Reference
derived
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Protective Effect of Statin on Sleep Deprivation
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