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Sleep DeprivationNCT02496962

Protective Effect of Statin on Sleep Deprivation

A study testing Atorvastatin in people with Sleep Deprivation, run by Shi Yang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Deprivation
What is being tested?
Atorvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteChina
Study dates
Jul 2015to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy subjects without cardiovascular disease

Who cannot join

  • hypertension
  • diabetes mellitus
  • hyperthyroidism
  • taking medication known to affect cardiovascular, metabolic, gastrointestinal, or immune function
  • depression
  • anxiety disorders

Trial locations and contacts

1 site in 1 country.

yang shi, M.D. contact

+8610-66876231

301shiy@sina.cn

China1 site, 1 recruiting

  • PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Yang Shi, M.D., +8610-66876231, ggyyong@sina.com

    Yu Tang Wang, M.D.

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Atorvastatin, placebo
Keywords
sleep deprivation
Medical subject headings
Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called Lipitor

    atorvastatin were taken daily for 5 days

  • placeboDrug

    placebo were taken daily for 5 days

Study groups in NCT02496962
Study groupRoleWhat they receive
Statin groupExperimentaldrug: 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.
Receives: Drug: Atorvastatin
Control groupPlacebo comparatordrug: 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48-h sleep deprivation

Secondary outcomes (4)

  1. 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

    Measured: 48-h sleep deprivation

  2. a change in serum total cholesterol level

    serum total cholesterol level was measured after 48-h sleep deprivation

    Measured: 48-h sleep deprivation

  3. a change in serum high sensitivity C-reactive protein level

    serum high sensitivity C-reactive protein level was measured after 48-h sleep deprivation

    Measured: 48-h sleep deprivation

  4. a change in serum superoxide dismutase level

    serum superoxide dismutase level was measured after 48-h sleep deprivation

    Measured: 48-h sleep deprivation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02496962
Sponsor's protocol ID
S2015-091-01
Status last verified
Jul 2015
First submitted
5 Jul 2015
Last updated
14 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11838069

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

    PubMed 23631177

  • 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.

    PubMed 24387767

  • 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.

    PubMed 23179915

  • 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.

    PubMed 27799236

Questions about this trial

What is this clinical trial studying?

A study testing Atorvastatin in people with Sleep Deprivation, run by Shi Yang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yang shi, M.D. (+8610-66876231, 301shiy@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a change in low-frequency (LF)/ high frequency (HF) (time frame: 48-h sleep deprivation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02496962, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.

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