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

• ClinicalTrials.gov Identifier: NCT01920334
• Recruitment Status: Unknown
• First Posted: August 12, 2013
• Last Update Posted: August 12, 2013
• Sponsor: Associação Fundo de Incentivo à Pesquisa
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Information provided by (Responsible Party): Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa

Tracking Information

• First Submitted Date: August 7, 2013
• First Posted Date: August 12, 2013
• Last Update Posted Date: August 12, 2013
• Study Start Date: July 2013
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2013)

Sleep efficiency [ Time Frame: 1 day - the first night ]

A full-night polysomnography is conducted in the first night on the ICU

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 8, 2013)

• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 8, 2013)

• 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
• Official Title: Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Acute Coronary Syndrome
• Sleep Deprivation

Intervention

• 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
• 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

Study Arms

• 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
  Intervention: Drug: Zolpidem 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
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 8, 2013): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2014
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01920334
• Other Study ID Numbers: 1442/11, Ethics Committee; CardioHE, AFIP ( Other Identifier: AFIP )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Patrick Rademaker Burke, Associação Fundo de Incentivo à Pesquisa
• Study 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

• PRS Account: Associação Fundo de Incentivo à Pesquisa
• Verification Date: August 2013