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

Sponsor

Associação Fundo de Incentivo à Pesquisa (Other)

Overall Status

Unknown status

CT.gov ID

NCT01920334

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

100

Enrollment

Location

Arms

Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sleep efficiency [1 day - the first night]
A full-night polysomnography is conducted in the first night on the ICU

Secondary Outcome Measures

Troponin T [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
Creatine-kinase MB [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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