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
NCT number | NCT02496962 |
Other study ID # | S2015-091-01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | July 5, 2015 |
Last updated | July 10, 2015 |
Start date | July 2015 |
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shi Yang |
China,
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
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 |
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