Achieving results

We developed Narval CC™ to optimise patient compliance and treatment efficacy with the conviction that compliance is directly related to comfort. Narval CC was designed to minimise the problems of patient discomfort by decreasing bulk, eliminating invasion of tongue space and enabling freedom of mandibular movement.

Clinical benefits

ORCADES1 is a ResMed five-year multicenter study on mandibular respositioning devices (MRDs), which is taking clinical evidence to the next level with the follow-up of 360 patients. The study’s interim results have been presented on 143 mild to severe obstructive sleep apnoea patients treated with Narval CC, who were followed up for three months. They confirm excellent results from previous studies2-3 by showing:

  • An 84% success rate, irrespective of OSA severity
  • A reduction of AHI to under 10 in 63% of patients
  • A significant reduction of the oxygen desaturation index, from 21 to 8
  • Loud snoring completely resolved in 90% of patients affected
  • Quality of life, fatigue score and sleep quality significantly improved

In their earlier one-year follow-up study of 129 mild to severe OSA patients, Geraads et al. showed that Narval CC's efficacy was maintained or slightly improved after one year in terms of lowering both AHI and sleepiness.2

Excellent compliance

Narval CC is very well tolerated by patients. In their 45-day follow-up study of 35 mild to severe OSA patients, Vecchierini et al. reported that 80% of patients wore Narval CC every night of the week.In the ORCADESstudy, patients wore Narval CC for an average of 6.7 hours a night for an average 6.6 nights a week.

What to look for in a custom-made MRD

Optimal treatment of OSA is based on efficacy (significantly reducing AHI and symptoms) and compliance (wearing an MRD as often and for as long as possible). Efficacy and compliance are usually reported in clinical studies. Check whether these factors have been documented for the device you’re considering for your patients.

An MRD should be thin, light, discreet and comfortable. It should precisely capture oral anatomy to seamlessly find its place in your patient’s mouth. It should also allow for natural jaw movement to help with acceptance and compliance. An MRD should be robust and durable enough to efficiently hold your patient’s mandible in a forward position in the long term. Protrusion should be easily adaptable, and in small increments to ease the titration process and find the best balance between efficacy and comfort. With its innovative design combined with advanced CAD/CAM technology, Narval CC is the next generation custom-made MRD, created to meet all these expectations and more.

References

  • 01

    Meurice et al. ORCADES: a prospective cohort study of severe obstructive sleep apnoea (OSA) patients receiving second line-treatment with a mandibular repositioning device (MRD). Eur Resp J 2013; 42(57):1056S. 3-months follow-up of 143 mild to severe OSA patients. Success rate defined as 50% AHI reduction.

  • 02

    Geraads et al. First intention management of obstructive sleep apnea syndrome (OSAS) by custom-made mandibular advancement device: The medium-term results. Prospective study by the General Hospital Pneumologists College (CPHG), Rev Pneumol Clin. 2010 Oct;66(5):284-92. 1 year follow-up of 129 mild to severe OSA patients.

  • 03

    Vecchierini et al. Efficacy and compliance of mandibular repositioning device in obstructive sleep apnea syndrome under a patient-driven protocol of care, Sleep Medicine 9 (2008) 762–769. 45 days follow up of 35 mild to severe OSA patients.

* This product may not be available in all countries.

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