NCT02496962

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

July 5, 2015

Last Update Submit

July 10, 2015

Conditions

Sleep Deprivation

Keywords

sleep deprivation

Outcome Measures

Primary Outcomes (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.

    48-h sleep deprivation

Secondary Outcomes (4)

  • a change in the frequency of premature atrial and ventricular complexes

    48-h sleep deprivation

  • a change in serum total cholesterol level

    48-h sleep deprivation

  • a change in serum high sensitivity C-reactive protein level

    48-h sleep deprivation

  • a change in serum superoxide dismutase level

    48-h sleep deprivation

Other Outcomes (1)

  • a composite outcome (the incidences of treatment-emergent adverse events)

    48-h sleep deprivation

Study Arms (2)

Statin group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

AtorvastatinDRUG

atorvastatin were taken daily for 5 days

Also known as: Lipitor
Statin group
placeboDRUG

placebo were taken daily for 5 days

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects without cardiovascular disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 11838069BACKGROUND

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

    PMID: 23631177BACKGROUND

  • 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.

    PMID: 24387767BACKGROUND

  • 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.

    PMID: 23179915RESULT

  • 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.

    PMID: 27799236DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

yang shi, M.D.

CONTACT

+8610-66876231301shiy@sina.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

CN(1)