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

Primary Purpose

Acute Coronary Syndrome, Sleep Deprivation

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Zolpidem CR 12.5mg
Placebo
Sponsored by
Associação Fundo de Incentivo à Pesquisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring coronary disease, heart diseases, enzymes, sleep, troponin, zolpidem

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zolpidem CR 12.5mg

Placebo

Arm Description

Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital

Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Troponin T
The serum troponin T is measured previously of the intervention and daily for 3 consecutive days
Creatine-kinase MB
The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days

Full Information

First Posted
August 7, 2013
Last Updated
August 8, 2013
Sponsor
Associação Fundo de Incentivo à Pesquisa
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01920334
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associação Fundo de Incentivo à Pesquisa
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Sleep Deprivation
Keywords
coronary disease, heart diseases, enzymes, sleep, troponin, zolpidem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zolpidem CR 12.5mg
Arm Type
Experimental
Arm Description
Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital
Intervention Type
Drug
Intervention Name(s)
Zolpidem CR 12.5mg
Other Intervention Name(s)
Stillnox CR 12.5mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Sleep efficiency
Description
A full-night polysomnography is conducted in the first night on the ICU
Time Frame
1 day - the first night
Secondary Outcome Measure Information:
Title
Troponin T
Description
The serum troponin T is measured previously of the intervention and daily for 3 consecutive days
Time Frame
Within the first 3 days after an acute coronary syndrome diagnosis
Title
Creatine-kinase MB
Description
The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days
Time Frame
Within the first 3 days after an acute coronary syndrome diagnosis
Other Pre-specified Outcome Measures:
Title
Sleep quality analogue visual scale
Description
After receiving the drug or placebo at night, the next morning the patients fill in the sleep quality visual analogue scale
Time Frame
3 consecutive mornings
Title
The Pittsburgh Sleep Quality Index
Description
Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index
Time Frame
1 day, before the intervention
Title
Epworth Sleepiness Scale
Description
Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale
Time Frame
1 day, before the intervention
Title
Insomnia Severity Index
Description
Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index
Time Frame
1 day, before the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick R Burke, MD
Phone
55-11-964288591
Email
doctorburke@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dalva R Poyares, MD PhD
Phone
55-11-21490155
Email
poyares@unifesp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick R Burke, MD
Organizational Affiliation
Associação Fundo de Incentivo à Pesquisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital São Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick R Burke, MD
Phone
55-11-964288591
Email
doctorburke@hotmail.com
First Name & Middle Initial & Last Name & Degree
Aline G Bittencourt, MD
Phone
55-11-964287637
Email
alinebittencourt@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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