Acute Coronary Syndrome, Sleep Deprivation
Conditions
Keywords
coronary disease, heart diseases, enzymes, sleep, troponin, zolpidem
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.
Interventions
DRUGZolpidem 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
DRUGPlacebo
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
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Associação Fundo de Incentivo à Pesquisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | 1 day - the first night | A full-night polysomnography is conducted in the first night on the ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | 1 day, before the intervention | Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index |
| Epworth Sleepiness Scale | 1 day, before the intervention | Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale |
| 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 |
Countries
Brazil
Contacts
Primary ContactPatrick R Burke, MD
Backup ContactDalva R Poyares, MD PhD
Outcome results
None listed