Pilot Study of a New Adjustable Thermoplastic Mandibular Advancement Device for the Management of Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Brief Research Letter

BACKGROUND: 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. OBJECTIVE: To assess the effectiveness of a new professionally-fitted PAT-MAD in patients with OSAHS in Morocco. METHOD: 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. RESULTS: 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. CONCLUSION: 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.