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

Associação Fundo de Incentivo à Pesquisa

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome; Sleep Deprivation

Treatments: Drug: Placebo; Drug: Zolpidem CR 12.5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01920334

1442/11, Ethics Committee

CardioHE, AFIP (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Zolpidem CR 12.5mg

Experimental group

Description:

Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital

Treatment:

Drug: Zolpidem CR 12.5mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo