Ventricular Dysfunction Clinical Trial
— ZODIACOfficial title:
Adaptative Servoventilation Compliance in Left Ventricular Dysfunction Patients With Central Sleep Apnea: Benefit of One Month Hypnotic (Zopiclone) Versus Placebo
NCT number | NCT02820441 |
Other study ID # | 38RC15.175 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | June 2018 |
Verified date | June 2016 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | June 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | one month | |
Secondary | Average use of the Adapative Servo Ventilation device per day assessed by the device data | 3 months and 12 months | ||
Secondary | Residual Apnea, Hypopnea Index (number/hour) | Index assessed by device data | 12 months | |
Secondary | Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 1 month | ||
Secondary | Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 3 months | ||
Secondary | Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 12 month | ||
Secondary | Asthenia assessed by Pichot scale | 1 month | ||
Secondary | Asthenia assessed by Pichot scale | 3 months | ||
Secondary | Asthenia assessed by Pichot scale | 12 months | ||
Secondary | Changes in New York Heart Association score | 1 month | ||
Secondary | Changes in New York Heart Association score | 3 months | ||
Secondary | Changes in New York Heart Association score | 12 months | ||
Secondary | Number of prescription of hypnotics drug | 12 months |
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