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

Last updated: August 8, 2013
Sponsor: Associação Fundo de Incentivo à Pesquisa
Overall Status: Trial Status Unknown

Phase

4

Condition

Insomnia

Sleep Disorders

Cardiac Ischemia

Treatment

N/A

Clinical Study ID

NCT01920334
1442/11, Ethics Committee
CardioHE, AFIP
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 100
Study Start date:
July 01, 2013
Estimated Completion Date:
January 31, 2014

Study 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.

Connect with a study center

  • Hospital São Paulo

    Sao Paulo, SP 04023062
    Brazil

    Active - Recruiting

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