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

Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; Sleep Deprivation
• Intervention / Treatment: Drug: Zolpidem CR 12.5mg; Drug: Placebo

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patrick R Burke, MD; Phone Number: 55-11-964288591; Email: doctorburke@hotmail.com
• Study Contact Backup: Name: Dalva R Poyares, MD PhD; Phone Number: 55-11-21490155; Email: poyares@unifesp.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023062
      • Recruiting
      • Hospital Sao Paulo
      • Contact: Patrick R Burke, MD; Phone Number: 55-11-964288591; Email: doctorburke@hotmail.com
      • Contact: Aline G Bittencourt, MD; Phone Number: 55-11-964287637; Email: alinebittencourt@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	A full-night polysomnography is conducted in the first night on the ICU	1 day - the first night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Troponin T	The serum troponin T is measured previously of the intervention and daily for 3 consecutive days	Within the first 3 days after an acute coronary syndrome diagnosis
Creatine-kinase MB	The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days	Within the first 3 days after an acute coronary syndrome diagnosis

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality analogue visual scale	After receiving the drug or placebo at night, the next morning the patients fill in the sleep quality visual analogue scale	3 consecutive mornings
The Pittsburgh Sleep Quality Index	Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index	1 day, before the intervention
Epworth Sleepiness Scale	Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale	1 day, before the intervention
Insomnia Severity Index	Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index	1 day, before the intervention

Collaborators and Investigators

• Sponsor: Associação Fundo de Incentivo à Pesquisa
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Patrick R Burke, MD, Associação Fundo de Incentivo à Pesquisa

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): October 1, 2013
• Study Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (ESTIMATE): August 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: sleep; coronary disease; troponin; zolpidem; heart diseases; enzymes
• Additional Relevant MeSH Terms: Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Acute Coronary Syndrome; Sleep Deprivation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: 1442/11, Ethics Committee; CardioHE, AFIP (OTHER: AFIP)