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Completed

NCT Number: NCT02112435

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Montréal, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Somnyx ®

Device

Active mandibular advancement splint

Other names: Active mandibular advancement appliance, Oral appliance

Narval ORM ® or SomnoDent ®

Device

Mandibular advancement splint

Other names: Mandibular advancement splint, Mandibular advancement appliance, Oral appliance, Mandibular repositioning appliance, Mandibular repositioning splint

Primary outcomes

  1. Overall response rate

    Time frame: following 3 months of treatment

    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 outcomes

  1. Rate of Complete Response

    Time frame: following 3 months of treatment

    Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night)

  2. Partial response rate

    Time frame: Following 3 months of treatment

    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.

  3. Subjective compliance

    Time frame: Following 3 months of treatment

    Subjective compliance

  4. Sleep quality

    Time frame: Following 3 months of treatment

    sleep efficiency, total sleep time

  5. Desaturation

    Time frame: Following 3 months of treatment

    desaturation index, time spent below 90%

  6. Subjective sleep

    Time frame: Following 3 months of treatment

    Pittsburgh questionnaire

  7. Quality of life

    Time frame: Following 3 months of treatment

    Functional outcomes sleep questionnaire (FOSQ)

  8. Fatigue

    Time frame: Following 3 months of treatment

    Chalder fatigue questionnaire

  9. Subjective daytime sleepiness

    Time frame: Following 3 months of treatment

    Epworth sleepiness score

  10. Side effects

    Time frame: Following 3 months of treatment

    side effects and interactions with the dental evaluations

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere
  • University Hospital, Montpellier

Registry information

Official study title

Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea

Acronym: SOMNYX

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2014
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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