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

NCT ID: NCT01920334

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-01-31

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.

Conditions

Acute Coronary Syndrome; Sleep Deprivation

Keywords

coronary disease; heart diseases; enzymes; sleep; troponin; zolpidem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Zolpidem CR 12.5mg

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Stillnox CR 12.5mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: lead

Responsible Party

Patrick Rademaker Burke

Sleep Medicine PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick R Burke, MD

Role: PRINCIPAL_INVESTIGATOR

Associação Fundo de Incentivo à Pesquisa

Locations

Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patrick R Burke, MD

Role: CONTACT

Phone: 55-11-964288591

Email: doctorburke@hotmail.com

Dalva R Poyares, MD PhD

Role: CONTACT

Phone: 55-11-21490155

Email: poyares@unifesp.br

Facility Contacts

Patrick R Burke, MD

Role: primary

Aline G Bittencourt, MD

Role: backup

Other Identifiers

CardioHE, AFIP

Identifier Type: OTHER

Identifier Source: secondary_id

1442/11, Ethics Committee

Identifier Type: -

Identifier Source: org_study_id