Protective Effect of Statin on Sleep Deprivation

July 10, 2015 updated by: Shi Yang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin group
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: Atorvastatin
atorvastatin were taken daily for 5 days
Other Names:
  • Lipitor
Placebo Comparator: Control group
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.
Drug: placebo
placebo were taken daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a change in low-frequency (LF)/ high frequency (HF)
Time Frame: 48-h sleep deprivation
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a change in the frequency of premature atrial and ventricular complexes
Time Frame: 48-h sleep deprivation
The frequency of premature atrial and ventricular complexes during 48-h sleep deprivation were measured by continuous ambulatory electrocardiogram monitoring
48-h sleep deprivation
a change in serum total cholesterol level
Time Frame: 48-h sleep deprivation
serum total cholesterol level was measured after 48-h sleep deprivation
48-h sleep deprivation
a change in serum high sensitivity C-reactive protein level
Time Frame: 48-h sleep deprivation
serum high sensitivity C-reactive protein level was measured after 48-h sleep deprivation
48-h sleep deprivation
a change in serum superoxide dismutase level
Time Frame: 48-h sleep deprivation
serum superoxide dismutase level was measured after 48-h sleep deprivation
48-h sleep deprivation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
a composite outcome (the incidences of treatment-emergent adverse events)
Time Frame: 48-h sleep deprivation
Treatment-emergent adverse events (TEAEs): abnormal liver function, renal insufficiency and constipation
48-h sleep deprivation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shi Yang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 5, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2015-091-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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