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Trial record 27 of 120 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

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Sleep Deprivation Drug: Zolpidem CR 12.5mg Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit
Study Start Date : July 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

Placebo Comparator: Placebo
Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
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




Primary Outcome Measures :
  1. Sleep efficiency [ Time Frame: 1 day - the first night ]
    A full-night polysomnography is conducted in the first night on the ICU


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920334


Contacts
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Contact: Patrick R Burke, MD 55-11-964288591 doctorburke@hotmail.com
Contact: Dalva R Poyares, MD PhD 55-11-21490155 poyares@unifesp.br

Locations
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Brazil
Hospital São Paulo Recruiting
Sao Paulo, SP, Brazil, 04023062
Contact: Patrick R Burke, MD    55-11-964288591    doctorburke@hotmail.com   
Contact: Aline G Bittencourt, MD    55-11-964287637    alinebittencourt@hotmail.com   
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Patrick R Burke, MD Associação Fundo de Incentivo à Pesquisa

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Responsible Party: Patrick Rademaker Burke, Sleep Medicine PhD Student, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01920334     History of Changes
Other Study ID Numbers: 1442/11, Ethics Committee
CardioHE, AFIP ( Other Identifier: AFIP )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013
Keywords provided by Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa:
coronary disease
heart diseases
enzymes
sleep
troponin
zolpidem
Additional relevant MeSH terms:
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Zolpidem
Sleep Aids, Pharmaceutical
Sleep Deprivation
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action