Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance
NCT ID: NCT02820441
Last Updated: 2021-05-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
2 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-05-31
Study Completion Date
2018-06-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Sleep Apnea, Central
Ventricular Dysfunction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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ZOPICLONE
Zopiclone 3.5 mg capsule by mouth daily for 2 weeks
Group Type
EXPERIMENTAL
Zopiclone
Intervention Type
DRUG
PLACEBO
Placebo 3.5 mg capsule by mouth daily for 2 weeks
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Interventions
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Zopiclone
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Other Intervention Names
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IMOVANE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marie DESTORS, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble Alpes, FRANCE
Locations
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Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes
Grenoble, , France
Site Status
Countries
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France
References
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Other Identifiers
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38RC15.175
Identifier Type: -
Identifier Source: org_study_id
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