Pilot Study of a New Adjustable Thermoplastic Mandibular Advancement Device for the Management of Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Brief Research Letter
Mohammed El Ibrahimi1, *, Mounir Laabouri2
Identifiers and Pagination:Year: 2016
First Page: 46
Last Page: 50
Publisher ID: TORMJ-10-46
Article History:Received Date: 25/3/2016
Revision Received Date: 6/5/2016
Acceptance Date: 10/5/2016
Electronic publication date: 15/07/2016
Collection year: 2016
open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/legalcode), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.
Prefabricated adjustable thermoplastic mandibular advancement devices (PAT-MADs) are a practical short-term treatment for obstructive sleep apnoea-hypopnoea syndrome (OSAHS) in patients who have failed or refused continuous positive airway pressure (CPAP) therapy.
To assess the effectiveness of a new professionally-fitted PAT-MAD in patients with OSAHS in Morocco.
Twenty-four adults with mild, moderate or severe OSAHS were fitted with the PAT-MAD (BluePro®; BlueSom, France). Respiratory parameters (apnoea-hypopnoea index (AHI), oxygen desaturation index (ODI)) and daytime sleepiness using the Epworth Sleepiness scale (ESS) were assessed before and after treatment. Adverse events were recorded.
Mean treatment duration was 106.3 ± 73.4 days. Mean AHI score decreased from 21.4 ± 7.4 to 9.3 ± 4.1 after treatment (p<0.0001) (mean reduction of 57.0 ± 12.3%). Mean ESS and ODI also decreased at EOS (from 10.4 ± 2.8 to 7.3 ± 2.3, mean reduction 30.3 ± 12.2%, p=0.0001; and 7.0 ± 6.9 to 4.7 ± 4.0, mean reduction 30.5 ± 25.0%, p=0.2, respectively). Treatment was considered to have been successful in 22 patients (91.7%) who had mild OSAHS or an AHI score of ≤5 at the end of the study. The device was well-tolerated.
This new PAT-MAD appears to be effective at reducing respiratory parameters and improving daytime alertness in patients with OSAHS. Long term studies in a larger number of patients are warranted to assess the long-term efficacy, retention and side-effects of this device.