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Sleep Apnea, CentralPhase 4ZODIACNCT02820441

Benefit of One Month Zopiclone Intake on Adaptative Servoventilation Compliance

A Phase 4 study testing Zopiclone in people with Sleep Apnea, Central and Ventricular Dysfunction, run by University Hospital, Grenoble at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Sleep Apnea, Central, Ventricular Dysfunction
What is being tested?
Zopiclone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteFrance
Study dates
May 2016to Jun 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Grenoble, 38043

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Zopiclone, Placebo
Medical subject headings
Sleep Apnea, Central, Ventricular Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZopicloneDrug

    Also called IMOVANE

  • PlaceboDrug

Study groups in NCT02820441
Study groupRoleWhat they receive
ZOPICLONEExperimentalZopiclone 3.5 mg capsule by mouth daily for 2 weeks
Receives: Drug: Zopiclone
PLACEBOPlacebo comparatorPlacebo 3.5 mg capsule by mouth daily for 2 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one month

Secondary outcomes (12)

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

    Measured: 3 months and 12 months

  2. Residual Apnea, Hypopnea Index (number/hour)

    Index assessed by device data

    Measured: 12 months

  3. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

    Measured: 1 month

  4. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

    Measured: 3 months

  5. Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

    Measured: 12 month

  6. Asthenia assessed by Pichot scale

    Measured: 1 month

  7. Asthenia assessed by Pichot scale

    Measured: 3 months

  8. Asthenia assessed by Pichot scale

    Measured: 12 months

  9. Changes in New York Heart Association score

    Measured: 1 month

  10. Changes in New York Heart Association score

    Measured: 3 months

  11. Changes in New York Heart Association score

    Measured: 12 months

  12. Number of prescription of hypnotics drug

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionSep 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02820441
Sponsor's protocol ID
38RC15.175
Acronym
ZODIAC
Status last verified
Jun 2016
First submitted
7 Jun 2016
Last updated
26 May 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Boccon-Gibod I, Bouillet L. [Angioedema and urticaria]. Ann Dermatol Venereol. 2014 Nov;141 Suppl 3:S586-95. doi: 10.1016/S0151-9638(14)70162-0. French.

    PubMed 25539680

  • Pagnier A. [Hereditary angioedema in childhood. Diagnosis and therapeutic challenges]. Presse Med. 2015 Jan;44(1):89-95. doi: 10.1016/j.lpm.2014.07.018. Epub 2014 Dec 12. French.

    PubMed 25511651

  • Dinkel HP, Maroske J, Schrod L. Sonographic appearances of the abdominal manifestations of hereditary angioedema. Pediatr Radiol. 2001 Apr;31(4):296-8. doi: 10.1007/s002470000409.

    PubMed 11321752

  • Bygum A. Hereditary angio-oedema in Denmark: a nationwide survey. Br J Dermatol. 2009 Nov;161(5):1153-8. doi: 10.1111/j.1365-2133.2009.09366.x. Epub 2009 Jun 22.

    PubMed 19709101

  • Farkas H. Pediatric hereditary angioedema due to C1-inhibitor deficiency. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):18. doi: 10.1186/1710-1492-6-18.

    PubMed 20667121

  • El-Hachem C, Amiour M, Guillot M, Laurent J. [Hereditary angioneurotic edema: a case report in a 3-year-old child]. Arch Pediatr. 2005 Aug;12(8):1232-6. doi: 10.1016/j.arcped.2005.03.052. French.

    PubMed 15890504

  • Farkas H. Management of upper airway edema caused by hereditary angioedema. Allergy Asthma Clin Immunol. 2010 Jul 28;6(1):19. doi: 10.1186/1710-1492-6-19.

    PubMed 20667122

  • Sanchez A, Ecochard A, Maestracci M, Rodiere M. [Hereditary angioedema causing colocolic intussusception]. Arch Pediatr. 2008 Mar;15(3):271-4. doi: 10.1016/j.arcped.2007.12.004. Epub 2008 Mar 10. French.

    PubMed 18329867

  • Pritzker HA, Levin TL, Weinberg G. Recurrent colocolic intussusception in a child with hereditary angioneurotic edema: reduction by air enema. J Pediatr Surg. 2004 Jul;39(7):1144-6. doi: 10.1016/j.jpedsurg.2004.03.075.

    PubMed 15213920

  • Parisi G, Chiarelli A, Squadrone NP, Galante E. Hereditary angioedema, a rare cause of recurrent abdominal pain. A report of 2 clinical cases and comments of a general nature Allergy Asthma Proc. 2013 Jul-Aug;34(4):312-27

  • MacGinnitie AJ. Pediatric hereditary angioedema. Pediatr Allergy Immunol. 2014 Aug;25(5):420-7. doi: 10.1111/pai.12168. Epub 2013 Dec 9.

    PubMed 24313851

  • Deroux A, Vilgrain I, Dumestre-Perard C, Boccon-Gibod I, Bouillet L. Towards a specific marker for acute bradykinin-mediated angioedema attacks: a literature review. Eur J Dermatol. 2015 Jul-Aug;25(4):290-5. doi: 10.1684/ejd.2015.2547.

    PubMed 25905454

  • Nussberger J, Cugno M, Cicardi M. Bradykinin-mediated angioedema. N Engl J Med. 2002 Aug 22;347(8):621-2. doi: 10.1056/NEJM200208223470820. No abstract available.

    PubMed 12192030

  • Cugno M, Zanichelli A, Bellatorre AG, Griffini S, Cicardi M. Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency. Allergy. 2009 Feb;64(2):254-7. doi: 10.1111/j.1398-9995.2008.01859.x. Epub 2008 Dec 4.

    PubMed 19076541

  • Hogan AD, Schwartz LB. Markers of mast cell degranulation. Methods. 1997 Sep;13(1):43-52. doi: 10.1006/meth.1997.0494.

    PubMed 9281467

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zopiclone in people with Sleep Apnea, Central and Ventricular Dysfunction, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average use of the Adapative Servo Ventilation device per day assessed by the device data (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820441, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.

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