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Protective Effect of Statin on Sleep Deprivation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02496962
Enrollment
72
Registered
2015-07-14
Start date
2015-07-31
Completion date
Unknown
Last updated
2015-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Deprivation

Keywords

sleep deprivation

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.

Interventions

DRUGAtorvastatin

atorvastatin were taken daily for 5 days

DRUGplacebo

placebo were taken daily for 5 days

Sponsors

Shi Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
a change in low-frequency (LF)/ high frequency (HF)48-h sleep deprivationThe primary efficacy endpoint was the effect of statin on LF/HF measured by continuous ambulatory electrocardiogram monitoring after 48-h sleep deprivation.

Secondary

MeasureTime frameDescription
a change in the frequency of premature atrial and ventricular complexes48-h sleep deprivationThe 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 level48-h sleep deprivationserum total cholesterol level was measured after 48-h sleep deprivation
a change in serum high sensitivity C-reactive protein level48-h sleep deprivationserum high sensitivity C-reactive protein level was measured after 48-h sleep deprivation
a change in serum superoxide dismutase level48-h sleep deprivationserum superoxide dismutase level was measured after 48-h sleep deprivation

Other

MeasureTime frameDescription
a composite outcome (the incidences of treatment-emergent adverse events)48-h sleep deprivationTreatment-emergent adverse events (TEAEs): abnormal liver function, renal insufficiency and constipation

Countries

China

Contacts

Primary Contactyang shi, M.D.
301shiy@sina.cn+8610-66876231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026