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

May 25, 2021 updated by: University Hospital, Grenoble

Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ZOPICLONE
Zopiclone 3.5 mg capsule by mouth daily for 2 weeks
Drug: Zopiclone
Other Names:
  • IMOVANE
PLACEBO_COMPARATOR: PLACEBO
Placebo 3.5 mg capsule by mouth daily for 2 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average use of the Adapative Servo Ventilation device per day assessed by the device data
Time Frame: one month
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
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average use of the Adapative Servo Ventilation device per day assessed by the device data
Time Frame: 3 months and 12 months
3 months and 12 months
Residual Apnea, Hypopnea Index (number/hour)
Time Frame: 12 months
Index assessed by device data
12 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time Frame: 1 month
1 month
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time Frame: 3 months
3 months
Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)
Time Frame: 12 month
12 month
Asthenia assessed by Pichot scale
Time Frame: 1 month
1 month
Asthenia assessed by Pichot scale
Time Frame: 3 months
3 months
Asthenia assessed by Pichot scale
Time Frame: 12 months
12 months
Changes in New York Heart Association score
Time Frame: 1 month
1 month
Changes in New York Heart Association score
Time Frame: 3 months
3 months
Changes in New York Heart Association score
Time Frame: 12 months
12 months
Number of prescription of hypnotics drug
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Marie DESTORS, MD, University Hospital, Grenoble Alpes, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (ESTIMATE)

July 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC15.175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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