ZODIAC: Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Terminated
CT.gov ID
NCT02820441
Collaborator
(none)
2
1
2
25
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 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
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Average use of the Adapative Servo Ventilation device per day assessed by the device data [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 [3 months and 12 months]

    2. Residual Apnea, Hypopnea Index (number/hour) [12 months]

      Index assessed by device data

    3. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) [1 month]

    4. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) [3 months]

    5. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) [12 month]

    6. Asthenia assessed by Pichot scale [1 month]

    7. Asthenia assessed by Pichot scale [3 months]

    8. Asthenia assessed by Pichot scale [12 months]

    9. Changes in New York Heart Association score [1 month]

    10. Changes in New York Heart Association score [3 months]

    11. Changes in New York Heart Association score [12 months]

    12. Number of prescription of hypnotics drug [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT02820441
    Other Study ID Numbers:
    • 38RC15.175
    First Posted:
    Jul 1, 2016
    Last Update Posted:
    May 26, 2021
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2021