Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

NCT02820441 | Terminated Phase 4

• 1 other identifier: 38RC15.175
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Central; Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Average use of the Adapative Servo Ventilation device per day assessed by the device data

  3 months and 12 months

• Residual Apnea, Hypopnea Index (number/hour)

  12 months

• Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

  1 month

• Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

  3 months

• Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

  12 month

Study Arms (2)

ZOPICLONE

EXPERIMENTAL

Zopiclone 3.5 mg capsule by mouth daily for 2 weeks

Drug: Zopiclone

PLACEBO

PLACEBO COMPARATOR

Placebo 3.5 mg capsule by mouth daily for 2 weeks

Drug: Placebo

Interventions

Zopiclone DRUG

Also known as: IMOVANE

ZOPICLONE

Placebo DRUG

PLACEBO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Clinique de Physiologie Sommeil et Exercice, Pole Thorax et Vaisseaux , University Hospital Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (40)

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MeSH Terms

Conditions

Sleep Apnea, Central; Ventricular Dysfunction

Interventions

zopiclone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Marie DESTORS, MD

  University Hospital, Grenoble Alpes, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: July 1, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: June 1, 2018
• Last Updated: May 26, 2021

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)