Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea (SOMNYX)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Université de Montréal
Sponsor:
Collaborators:
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Montpellier
Hospital Porto, Portugal
Polyclinique de Bordeaux-Tondu
Stanford University
Information provided by (Responsible Party):
Nelly Huynh, Université de Montréal
ClinicalTrials.gov Identifier:
NCT02112435
First received: April 5, 2014
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.


Condition Intervention
Obstructive Sleep Apnea
Device: Somnyx ®
Device: Narval ORM ® or SomnoDent ®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: following 3 months of treatment ] [ Designated as safety issue: No ]
    Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI <15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night


Secondary Outcome Measures:
  • Rate of Complete Response [ Time Frame: following 3 months of treatment ] [ Designated as safety issue: No ]
    Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night)

  • Partial response rate [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    Partial response rate =% of patients with reduction AHI ≥ 50% with AHI> 15 or AHI <15 with reduction <50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment.

  • Subjective compliance [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    Subjective compliance

  • Sleep quality [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    sleep efficiency, total sleep time

  • Desaturation [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    desaturation index, time spent below 90%

  • Subjective sleep [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    Pittsburgh questionnaire

  • Quality of life [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    Functional outcomes sleep questionnaire (FOSQ)

  • Fatigue [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    Chalder fatigue questionnaire

  • Subjective daytime sleepiness [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    Epworth sleepiness score

  • Side effects [ Time Frame: Following 3 months of treatment ] [ Designated as safety issue: No ]
    side effects and interactions with the dental evaluations


Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Narval ORM ® or SomnoDent ®
Mandibular advancement splint (Narval ORM ® or SomnoDent ®)
Device: Narval ORM ® or SomnoDent ®
Mandibular advancement splint
Other Names:
  • Mandibular advancement splint
  • Mandibular advancement appliance
  • Oral appliance
  • Mandibular repositioning appliance
  • Mandibular repositioning splint
Experimental: Somnyx ®
Active mandibular advancement splint (Somnyx ®)
Device: Somnyx ®
Active mandibular advancement splint
Other Names:
  • Active mandibular advancement appliance
  • Oral appliance

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 65 years
  • severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30
  • patient in failure or refusal of CPAP treatment
  • agree to participate and sign the consent form research
  • speak and understand French without external assistance
  • be in good health (no neurological or psychiatric syndrome).
  • have a valid Social Security card (in France and Portugal only)

Exclusion Criteria:

  • contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion
  • dental restorations in progress or planned in the next 6 months
  • psychiatric and neuromuscular disorders
  • untreated cardiovascular diseases and history of stroke or myocardial infarction
  • severe or morbid obesity (body mass index> 35)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112435

Contacts
Contact: Nelly Huynh, PhD nelly.huynh@umontreal.ca
Contact: Gilles Lavigne, DMD, PhD gilles.lavigne@umontreal.ca

Locations
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Christian Guilleminault, MD, Biol.D.       cguil@stanford.edu   
Principal Investigator: Christian Guilleminault, MD, Biol.D         
Canada, Quebec
Université de Montréal Not yet recruiting
Montreal, Quebec, Canada, H3C3J7
Contact: Nelly Huynh, PhD       nelly.huynh@umontreal.ca   
Contact: Gilles Lavigne, DMD, PhD       gilles.lavigne@umontreal.ca   
Principal Investigator: Nelly Huynh, PhD         
Sub-Investigator: Gilles Lavigne, DMD, PhD         
France
Polyclinique du Tondu Not yet recruiting
Bordeaux, France
Contact: Pierre-Jean Monteyrol, MD       pjmonteyrol@wanadoo.fr   
Principal Investigator: Pierre-Jean Monteyrol, MD         
Sub-Investigator: Jacques Taillard, PhD         
Université Montpellier Not yet recruiting
Montpellier, France
Contact: Yves Dauvilliers, MD       y-dauvilliers@chu-montpellier.fr   
Principal Investigator: Yves Dauvilliers, MD         
Sub-Investigator: Olivier Gallet de Santerre, MD         
Sub-Investigator: Isabelle Bonafé, DMD         
Groupe Hospitalier Pitie-Salpetriere Not yet recruiting
Paris, France
Contact: Carole Philippe, MD       carole.philippe@psl.aphp.fr   
Principal Investigator: Carole Philippe, MD         
Sub-Investigator: Valérie Attalie, MD         
Sub-Investigator: Stéfania Redolfi, MD         
Sub-Investigator: Isabelle Arnulf, MD         
Sub-Investigator: Jean-Marc Collet, MD         
Sub-Investigator: Patrick Goudot, PhD         
Portugal
Hospital CUF Porto Not yet recruiting
Porto, Portugal
Contact: Marta Gonçalves, MD       martaazevedogoncalves@gmail.com   
Principal Investigator: Marta Gonçalves, MD         
Sub-Investigator: Sandra Borges, DMD         
Sub-Investigator: Ana Pereira, DMD         
Sponsors and Collaborators
Université de Montréal
Groupe Hospitalier Pitie-Salpetriere
University Hospital, Montpellier
Hospital Porto, Portugal
Polyclinique de Bordeaux-Tondu
Stanford University
Investigators
Principal Investigator: Nelly Huynh, PhD Université de Montréal
  More Information

No publications provided

Responsible Party: Nelly Huynh, Assistant research professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT02112435     History of Changes
Other Study ID Numbers: 14-011-CERES-D, NH-14SRP-Somnyx
Study First Received: April 5, 2014
Last Updated: April 9, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Montréal:
obstructive sleep apnea
mandibular advancement splint
active mandibular advancement splint
oral appliance

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 11, 2014