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Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance (ZODIAC)

Primary Purpose

Sleep Apnea, Central, Ventricular Dysfunction

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Zopiclone
Placebo
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Apnea, Central

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged between 18 and 90 years at the initial visit
  • Central Sleep Apnea with an AHI ≥ 15/h and at least 50% of central events indicating an ASV therapy, as determined by a ventilatory polygraphy (PG) or a polysomnography (PSG)
  • Cardiac Dysfunction with Left Ventricular Ejection fraction(LVEF)> 45% determined by a transthoracic echocardiography (TTE), known for more than 12 weeks and stable for at least 4 weeks;
  • Compliance less than 3 hours after 7 days of the setting up of ASV;
  • Patient affiliated to a social security scheme or being beneficiary of such scheme;
  • Patient voluntarily participating in the research, with written informed consent

Exclusion Criteria:

  • Current use of continuous positive airway pressure (cPAP) for treatment of sleep apnea during the last 12 months
  • Presence of chronic symptomatic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 45%), and a CSA moderate to severe (AHI ≥15 / h)
  • Presence of severe pulmonary bullous disease
  • Presence of Pneumothorax or pneumomediastinum
  • Hypotension, especially if associated with depletion of intravascular volume
  • Dehydration
  • Leaking of cerebrospinal fluid, cranial surgery or trauma recently.
  • Episode of acute respiratory failure or heart failure in the previous month

Sites / Locations

  • Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZOPICLONE

PLACEBO

Arm Description

Zopiclone 3.5 mg capsule by mouth daily for 2 weeks

Placebo 3.5 mg capsule by mouth daily for 2 weeks

Outcomes

Primary Outcome Measures

Average use of the Adapative Servo Ventilation device per day assessed by the device data
daily use of the device (hours/day, mean value), amount of hours and number of day the device has been used as assessed by the device data

Secondary Outcome Measures

Average use of the Adapative Servo Ventilation device per day assessed by the device data
Residual Apnea, Hypopnea Index (number/hour)
Index assessed by device data
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Asthenia assessed by Pichot scale
Asthenia assessed by Pichot scale
Asthenia assessed by Pichot scale
Changes in New York Heart Association score
Changes in New York Heart Association score
Changes in New York Heart Association score
Number of prescription of hypnotics drug

Full Information

First Posted
June 7, 2016
Last Updated
May 25, 2021
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02820441
Brief Title
Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance
Acronym
ZODIAC
Official Title
Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with 14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.
Detailed Description
ASV remain the optimal treatment for CSA in Heart Failure patients with preserved left ventricular ejection fraction (LVEF). Yet, the adaptation to the ventilation is extremely challenging and the resulting difficulties encountered to sleep induction might be a reason for dropping out. Zopiclone is indicated for the short-term treatment of insomnia where sleep initiation or sleep maintenance are prominent symptoms. In this study, Zopiclone, as sedative and hypnotic agent, is used during the ASV initiation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Central, Ventricular Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZOPICLONE
Arm Type
Experimental
Arm Description
Zopiclone 3.5 mg capsule by mouth daily for 2 weeks
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Placebo 3.5 mg capsule by mouth daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Zopiclone
Other Intervention Name(s)
IMOVANE
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Average use of the Adapative Servo Ventilation device per day assessed by the device data
Description
daily use of the device (hours/day, mean value), amount of hours and number of day the device has been used as assessed by the device data
Time Frame
one month
Secondary Outcome Measure Information:
Title
Average use of the Adapative Servo Ventilation device per day assessed by the device data
Time Frame
3 months and 12 months
Title
Residual Apnea, Hypopnea Index (number/hour)
Description
Index assessed by device data
Time Frame
12 months
Title
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time Frame
1 month
Title
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time Frame
3 months
Title
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time Frame
12 month
Title
Asthenia assessed by Pichot scale
Time Frame
1 month
Title
Asthenia assessed by Pichot scale
Time Frame
3 months
Title
Asthenia assessed by Pichot scale
Time Frame
12 months
Title
Changes in New York Heart Association score
Time Frame
1 month
Title
Changes in New York Heart Association score
Time Frame
3 months
Title
Changes in New York Heart Association score
Time Frame
12 months
Title
Number of prescription of hypnotics drug
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged between 18 and 90 years at the initial visit Central Sleep Apnea with an AHI ≥ 15/h and at least 50% of central events indicating an ASV therapy, as determined by a ventilatory polygraphy (PG) or a polysomnography (PSG) Cardiac Dysfunction with Left Ventricular Ejection fraction(LVEF)> 45% determined by a transthoracic echocardiography (TTE), known for more than 12 weeks and stable for at least 4 weeks; Compliance less than 3 hours after 7 days of the setting up of ASV; Patient affiliated to a social security scheme or being beneficiary of such scheme; Patient voluntarily participating in the research, with written informed consent Exclusion Criteria: Current use of continuous positive airway pressure (cPAP) for treatment of sleep apnea during the last 12 months Presence of chronic symptomatic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 45%), and a CSA moderate to severe (AHI ≥15 / h) Presence of severe pulmonary bullous disease Presence of Pneumothorax or pneumomediastinum Hypotension, especially if associated with depletion of intravascular volume Dehydration Leaking of cerebrospinal fluid, cranial surgery or trauma recently. Episode of acute respiratory failure or heart failure in the previous month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie DESTORS, MD
Organizational Affiliation
University Hospital, Grenoble Alpes, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
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Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

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