Abstract:
BACKGOUND AND OBJECTIVES:The disadvantages of custom-made mandibular advancement devices (MAD) for obstructive sleep apnoea (OSA) therapy are the cost and delay required to manufacture the device. This study aimed to evaluate the efficacy of a titrable, thermoplastic MAD compared to a custom-made MAD for OSA therapy. METHODS:In this prospective nonrandomized study, 158 patients with OSA from two French sleep centers were treated for 6 months with a titrable thermoplastic MAD (n = 86) or a custom-made MAD (n = 72). The primary outcome was the change in sleep-disordered breathing (SDB) severity. RESULTS:After adjustment for baseline values, age, body mass index and study site, no significant intergroup differences were observed between thermoplastic and custom-made MAD for the outcome of apnoea, hypopnoea and oxygen desaturation indices. No between treatment differences were observed for the outcome of subjective sleepiness, symptoms of snoring and fatigue, depressive symptoms, and quality of life. Thermoplastic MAD therapy was associated with higher side effects scores for tooth pain (p < 0.0001) and self-reported occlusal changes (p = 0.0069). Mean (SD) reported compliance was lower in the thermoplastic MAD group than in the custom-made MAD group (6.4 [0.2] vs 7.1 [0.1] h/night; p = 0.035). CONCLUSIONS:This study demonstrates the efficacy of a titrable thermoplastic MAD in reducing SDB and related symptoms in patients with mild to severe OSA. Reported compliance at 6 months was high despite more dental discomfort than with custom-made MAD.
journal_name
Respir Medjournal_title
Respiratory medicineauthors
Gagnadoux F,Nguyen XL,Le Vaillant M,Priou P,Meslier N,Eberlein A,Kun-Darbois JD,Chaufton C,Villiers B,Levy M,Trzépizur W,Launois Sdoi
10.1016/j.rmed.2017.08.004subject
Has Abstractpub_date
2017-10-01 00:00:00pages
35-42eissn
0954-6111issn
1532-3064pii
S0954-6111(17)30267-6journal_volume
131pub_type
临床试验,杂志文章abstract::Inhalation therapy is the mainstay of chronic obstructive pulmonary disease management, and inhaler selection can have a profound impact on drug delivery and medication adherence, as well as on treatment outcomes. Although multiple delivery systems, such as pressurized metered-dose inhalers, dry powder inhalers, slow-...
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pub_type: 临床试验,杂志文章,随机对照试验
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