Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

Ventricular Dysfunction Clinical Trial

— ZODIAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02820441
• Other study ID #: 38RC15.175
• Status: Terminated
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Ventricular Dysfunction

Intervention

Drug:
• Zopiclone

• Placebo

Locations

Country	Name	City	State
France	Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

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