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Trial record 26 of 118 for:    ZOLPIDEM AND AIDS

Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients

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ClinicalTrials.gov Identifier: NCT01920334
Recruitment Status : Unknown
Verified August 2013 by Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Sleep efficiency [ Time Frame: 1 day - the first night ]
A full-night polysomnography is conducted in the first night on the ICU
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • Troponin T [ Time Frame: Within the first 3 days after an acute coronary syndrome diagnosis ]
    The serum troponin T is measured previously of the intervention and daily for 3 consecutive days
  • Creatine-kinase MB [ Time Frame: Within the first 3 days after an acute coronary syndrome diagnosis ]
    The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2013)
  • Sleep quality analogue visual scale [ Time Frame: 3 consecutive mornings ]
    After receiving the drug or placebo at night, the next morning the patients fill in the sleep quality visual analogue scale
  • The Pittsburgh Sleep Quality Index [ Time Frame: 1 day, before the intervention ]
    Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index
  • Epworth Sleepiness Scale [ Time Frame: 1 day, before the intervention ]
    Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale
  • Insomnia Severity Index [ Time Frame: 1 day, before the intervention ]
    Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
Official Title  ICMJE Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
Brief Summary

A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug (zolpidem controlled release).

The study hypothesis is that sleeping better can improve the heart recovery in patients with a diagnosis of acute coronary syndrome.

Detailed Description

The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.

The objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.

A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes [troponin T and creatine kinase MB (CK-MB)] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Sleep Deprivation
Intervention  ICMJE
  • Drug: Zolpidem CR 12.5mg
    Patients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography
    Other Name: Stillnox CR 12.5mg
  • Drug: Placebo
    Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge
Study Arms  ICMJE
  • Experimental: Zolpidem CR 12.5mg
    Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
    Intervention: Drug: Zolpidem CR 12.5mg
  • Placebo Comparator: Placebo
    Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients from 18 to 75 years of age
  • Diagnosis of acute coronary syndrome
  • Capable of swallowing pills
  • Capable of filling in the questionaires

Exclusion Criteria:

  • Class IV heart failure according to the New York heart association functional class,
  • Patients in a coma
  • Patients receiving mechanical ventilation
  • Patients who regularly use benzodiazepines or other medications for inducing sleep
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920334
Other Study ID Numbers  ICMJE 1442/11, Ethics Committee
CardioHE, AFIP ( Other Identifier: AFIP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa
Study Sponsor  ICMJE Associação Fundo de Incentivo à Pesquisa
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
Principal Investigator: Patrick R Burke, MD Associação Fundo de Incentivo à Pesquisa
PRS Account Associação Fundo de Incentivo à Pesquisa
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP