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

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ClinicalTrials.gov Identifier: NCT02820441
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : July 1, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Central Ventricular Dysfunction Drug: Zopiclone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo
Study Start Date : May 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: ZOPICLONE
Zopiclone 3.5 mg capsule by mouth daily for 2 weeks
Drug: Zopiclone
Other Name: IMOVANE

Placebo Comparator: PLACEBO
Placebo 3.5 mg capsule by mouth daily for 2 weeks
Drug: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Average use of the Adapative Servo Ventilation device per day assessed by the device data [ Time Frame: 3 months and 12 months ]
  2. Residual Apnea, Hypopnea Index (number/hour) [ Time Frame: 12 months ]
    Index assessed by device data

  3. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: 1 month ]
  4. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: 3 months ]
  5. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) [ Time Frame: 12 month ]
  6. Asthenia assessed by Pichot scale [ Time Frame: 1 month ]
  7. Asthenia assessed by Pichot scale [ Time Frame: 3 months ]
  8. Asthenia assessed by Pichot scale [ Time Frame: 12 months ]
  9. Changes in New York Heart Association score [ Time Frame: 1 month ]
  10. Changes in New York Heart Association score [ Time Frame: 3 months ]
  11. Changes in New York Heart Association score [ Time Frame: 12 months ]
  12. Number of prescription of hypnotics drug [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820441


Contacts
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Contact: Marie DESTORS, MD +33 (0)476 769 265 mdestors@chu-grenoble.fr
Contact: Andry RAKOTOVAO, PhD +33 (0)476 766 148 arakotovao@chu-grenoble.fr

Locations
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France
Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes Recruiting
Grenoble, France, 38043
Contact: Marie DESTORS, MD, BSc    +33 (0)476 769 265    mdestors@chu-grenoble.fr   
Contact: Andry RAKOTOVAO, PhD    +33 (0)476 766 148    arakotovao@chu-grenoble.fr   
Sub-Investigator: Renaud TAMISIER, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Marie DESTORS, MD University Hospital, Grenoble Alpes, FRANCE
Publications:
Parisi G, Chiarelli A, Squadrone NP, Galante E. Hereditary angioedema, a rare cause of recurrent abdominal pain. A report of 2 clinical cases and comments of a general nature Allergy Asthma Proc. 2013 Jul-Aug;34(4):312-27
Brevet: w/o 2008 062314 circulating ve-cadherin as a predictive marker of sensitivity or resistance to anti-tumoral treatment, and improved method for the detection of soluble proteins.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02820441    
Other Study ID Numbers: 38RC15.175
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Central
Ventricular Dysfunction
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Zopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs