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Obstructive Sleep Apnea SyndromeORCADESNCT01326143

Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH)

An observational study of Obstructive Sleep Apnea Syndrome, run by ResMed at 26 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea Syndrome
What is being tested?
ORM Narval MRD
Type of treatment
Medical device
How many people
360 participants
Where
26 sitesFrance
Study dates
May 2011to 27 Feb 2019
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Severe Obstructive Sleep Apnea Hypopnea

Who may be able to join

  • Adult patient with severe OSAH (AHI > 30 or AHI of between 5 and 30 along with severe daytime sleepiness),
  • intolerant to or having refused CPAP therapy,
  • no dental, parodontal or articulatory contraindications,
  • no experience of any mandibular advancement device therapy,
  • medical insurance.

Who cannot join

  • severe psychiatric disorders or severe neuromuscular disorders
  • > 20% of central apneas during the baseline assessment,
  • severe OSAH with an AHI > 30 associated with another sleep pathology (narcolepsy with or without cataplexy, idiopathic hypersomnia, severe restless legs syndrome),
  • pregnant or breastfeeding woman,
  • Informed consent not signed,
  • patient requiring special protection such as patients with appointed guardians and patients without legal or administrative rights,
  • patient who is completely or partially edentulous

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • Fondation Bon Sauveur / cabinet médical / cabinet dentaire

    Albi

  • CH Antibes / cabinet dentaire

    Antibes

  • CH Béziers

    Béziers

  • CHU Avicennes

    Bobigny

  • Polyclinique du Tondu / cabinet dentaire

    Bordeaux

  • CHG Chalon en Champagne

    Châlons-en-Champagne

  • CH Compiègne Senlis / cabinets dentaires

    Compiègne

  • CHU Grenoble

    Grenoble

  • Cabinet médical / cabinet dentaire

    Lagny

  • CHRU Lille

    Lille

  • Cabinet médical Lyon

    Lyon

  • CHU La Timone / cabinet médical

    Marseille

  • CHRU Montpellier / Clinique Beau Soleil / Faculté d'Odontologie / cabinet dentaire

    Montpellier

  • CH Montreuil

    Montreuil

  • Centre Médical Plateau de Haye / cabinet médical / cabinet dentaire

    Nancy

  • Maison de la Mutualité / polyclinique de l'Atlantique

    Nantes

  • Cabinet médical / cabinet dentaire

    Nice

  • Hôpital Bichat Claude Bernard

    Paris

  • Hôpital Pitié Salpetriere

    Paris

  • Hôtel Dieu

    Paris

  • CHU Poitiers

    Poitiers

  • CHRU Rennes / polyclinique St Laurent / cabinet dentaire

    Rennes

  • CHRU Rouen

    Rouen

  • CHU Toulouse

    Toulouse

  • Clinique de l'Union

    Toulouse

  • CH Valence

    Valence

Other trials in France

About this study

Official title: ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH

The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP) treatment.

Read the detailed description

OSAH is a common condition which occurs in between 1 and 4% of the adult population. Respiratory obstruction may be complete (apnea) or incomplete (hypopnea). This disorder disturbs the architecture and quality of sleep, and is a known risk factor in the development of cardiovascular and metabolic diseases. CPAP is the standard treatment, however in some cases patients are unable to use it (rejection, intolerance, etc.). In such circumstances, treatment using a MRD may result in an improvement of symptoms.

Very few long-term clinical data are available on treatment of OSAH by MRD. This study should allow to have a precise and representative vision of 5 years results of ORM Narval MRD treatment in conditions of good practices (titration, controls of efficacy).

Being tested
ORM Narval MRD
Keywords
MRD, Narval, Oral appliance, Obstructive Sleep apnea, OSAH, OSA treatment
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

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

  • ORM Narval MRDDevice

Study groups in NCT01326143
Study groupRoleWhat they receive
ORM Narval MRDNot described
Receives: Device: ORM Narval MRD

What is being measured

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

  1. Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG)

    Measured: 5 years

Secondary outcomes (6)

  1. Percentage of patients with AHI reduced by at least 50% compared to baseline measured by PG/PSG

    Measured: 3 months and 2 years

  2. Percentage of patients who no longer suffer from severe daytime sleepiness (Epworth Sleepiness scale)

    Measured: 3 months, 2 years and 5 years

  3. Sleep quality of life (Quebec Sleep Questionaire)

    Measured: 3 months, 2 years and 5 years

  4. Percentage of patients who stopped the therapy for dento-maxillofacial side effects

    Measured: 6 months, 1, 2, 3, 4 and 5 years

  5. Percentage of patients with satisfactory compliance

    Measured: 3 months, 2 and 5 years.

  6. Fatigue score (Pichot questionaire)

    Measured: 3 months, 2 and 5 years

Timeline

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

  1. First posted30 Mar 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionFeb 2019
  4. Study completion27 Feb 2019

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01326143
Sponsor's protocol ID
RESMED Narval ORM 001
Other IDs
2010-A01121-38
Acronym
ORCADES
Status last verified
Mar 2020
First submitted
29 Mar 2011
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Vecchierini MF, Attali V, Collet JM, d'Ortho MP, El Chater P, Kerbrat JB, Leger D, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Meurice JC; ORCADES investigators. A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome: the ORCADES study. Sleep Med. 2016 Mar;19:131-40. doi: 10.1016/j.sleep.2015.05.020. Epub 2015 Jun 29.

    PubMed 26364869

  • Attali V, Vecchierini MF, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Tordjman F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators. Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data. Sleep Med. 2019 Nov;63:64-74. doi: 10.1016/j.sleep.2019.04.021. Epub 2019 Jun 12.

    PubMed 31606651

  • Vecchierini MF, Attali V, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Morin L, Mullens E, Pigearias B, Martin F, Khemliche H, Lerousseau L, Meurice JC; ORCADES investigators; Abedipour D, Allard-Redon A, Aranda A, Attali V, Bavozet F, Becu M, Beruben W, Bessard J, Bonafe I, Boukhana M, Chabrol B, Chatte G, Lebret C, Collet JM, Coste O, Dumont N, Durand-Amat S, D'ortho MP, Elbaum JM, De Santerre OG, Goutorbes F, Grandjean T, Guyot W, Hammer D, Havasi C, Huet P, Kerbrat JB, Khemliche H, Koltes C, Leger D, Lacassagne L, Laur X, Lerousseau L, Liard O, Loisel C, Longuet M, Mallart A, Martin F, Merle Beral F, Meurice JC, Mokhtari Z, Monaca C, Monteyrol PJ, Muir JF, Mullens E, Muller D, Paoli C, Petit FX, Pigearias B, Pradines M, Prigent A, Putterman G, Rey M, Samama M, Tamisier R, Tiberge M, Tison C, Tordjman F, Triolet B, Vacher C, Vecchierini MF, Verain A. Sex differences in mandibular repositioning device therapy effectiveness in patients with obstructive sleep apnea syndrome. Sleep Breath. 2019 Sep;23(3):837-848. doi: 10.1007/s11325-018-1766-8. Epub 2018 Dec 22.

    PubMed 30580418

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea Syndrome, run by ResMed at 26 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG) (time frame: 5 years). 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 NCT01326143, which also lists 3 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 2 Apr 2020.

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