Narval CC clinical research
There’s a growing body of clinical research that demonstrates the efficacy and compliance of mandibular repositioning devices (MRDs) in treating obstructive sleep apnoea and snoring. MRDs improve patient compliance and quality of life, and reduce both snoring and the apnoea-hypopnoea index (AHI).
The following clinical research papers demonstrate results in particular for ResMed’s Narval CC™ MRD.
A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea syndrome (OSASH): the ORCADES study
Published in Sleep Med. doi: 10.1016/j.sleep.2015.05.020
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 for the ORCADES investigator
- A five-year multicentre study covering 369 patients.
- Purpose is to prospectively determine the long-term efficacy and tolerability of 2 custom-made Narval CC MRDs for OSAHS patients.
- 3-to-6 month data is reported in the study
- 79% success rate in decreasing AHI by ≥50%
- 66% achieved complete success (AHI < 10/h)
- 89% stopped loud snoring
- Patients used Narval CC on average 6.7 hours per night, and 6.7 nights per week
Efficacy and compliance of mandibular repositioning device in obstructive sleep apnoea syndrome under a patient-driven protocol of care
Published in Sleep Med 2008;9(7):762-9
Vecchierini MF, Léger D, Laaban JP, Putterman G, Figueredo M, Levy J, Vacher C, Monteyrol PJ, Philip P.
- 40 patients — 10 with severe OSA (AHI ≥ 30) and 30 with moderate (AHI 15 to 30) — enrolled by 4 sleep centres. 35 completed the study
- Overall AHI reduced by 51%
- Narval CC demonstrated high level of compliance (86%)
Impact on temporomandibular joint (TMJ) of two mandibular advancement device designs
Published in ITBM-RBM 2006;27(5-6):223-237. DOI: 10.1016/j.rbmet.2007.01.004
Cheze L and Navailles B
- Designed to compare traction-based vs. compression-based devices, with mandible in a 10 mm protrusion position.
- Findings may imply an improved side effect and compliance profile in clinical practice for traction-based over compression-based devices.
- 10% less stress on the TMJ
First-line treatment of obstructive sleep apnoea syndrome (OSAS) by custom-made mandibular advancement appliance: medium-term results. Prospective study by the General Hospital Pneumologists College (CPHG)
Published in Rev Pneumol Clin 2010;66(5):284-92
Geraads A, d’Athis P, Lerousseau L, Larzul JJ, Bénichou M, Guyonnaud C, Figueredo M, Steinbauer J, Bedicam JM, Martin F, Just N, Gonzalez G, Devin E, Veyer AS
- Prospective 1-year multicentre study (13 general hospitals) between June 2006 and December 2007, covering 129 patients
- Purpose is to demonstrate efficacy and tolerance of present generation MRDs in first intention treatment, even in severe cases of OSA
- Overall AHI reduced by 56%
- Epworth Sleepiness Scale decreased by 38%
18 month assessment of 54 patients referred for treatment of anti-social snoring (AHI ≤ 30/hr) with a custom mandibular repositioning device
Published in Sleep Med 2011;12 (Suppl 1):S103
Dr. Roy Dookun, Private Dental Practice, United Kingdom
- Purpose is to evaluate snoring reduction, as well as effect on OSA-related symptoms, treatment compliance and side effects
- 39 patients completed whole protocol; data reported covers 18 months
- Narval CC demonstrated high level of compliance at 82%
- Narval CC significantly reduced overall TSS*-measured snoring by 84%
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