Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
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|ClinicalTrials.gov Identifier: NCT01920334|
Recruitment Status : Unknown
Verified August 2013 by Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa.
Recruitment status was: Recruiting
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||January 2014|
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 Name: 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
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
- Sleep efficiency [ Time Frame: 1 day - the first night ]A full-night polysomnography is conducted in the first night on the ICU
- Troponin T [ Time Frame: 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 [ Time Frame: 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
- Sleep quality analogue visual scale [ Time Frame: 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 [ Time Frame: 1 day, before the intervention ]Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index
- Epworth Sleepiness Scale [ Time Frame: 1 day, before the intervention ]Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale
- Insomnia Severity Index [ Time Frame: 1 day, before the intervention ]Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920334
|Contact: Patrick R Burke, MDemail@example.com|
|Contact: Dalva R Poyares, MD PhDfirstname.lastname@example.org|
|Hospital São Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 04023062|
|Contact: Patrick R Burke, MD 55-11-964288591 email@example.com|
|Contact: Aline G Bittencourt, MD 55-11-964287637 firstname.lastname@example.org|
|Principal Investigator:||Patrick R Burke, MD||Associação Fundo de Incentivo à Pesquisa|