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Randomized Crossover Trial of Two Treatments for Sleep Apnea/Hypopnea Syndrome

Continuous Positive Airway Pressure and Mandibular Repositioning Splint

Edinburgh Sleep Centre, Respiratory Medicine Unit; Department of Orthodontics; and Maxillo-Facial Unit, University of Edinburgh, Edinburgh, United Kingdom

Correspondence and requests for reprints should be addressed to Dr. Heather M. Engleman, Edinburgh Sleep Centre, Ward 48, Royal Infirmary of Edinburgh, Lauriston Place, Edinburgh EH3 9YW, UK. E-mail: h.engleman{at}ed.ac.uk

Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] 5/hour, and 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean ± SD], 46 ± 9 years; Epworth 14 ± 4; median AHI, 22/hour; interquartile ratio [IQR], 11–43/hour). Significant (p 0.01) differences between MRS and CPAP were observed for 7 of 21 variables (effect sizes, 0.3–0.6 SDs), all favoring CPAP, including AHI (15 ± 16 and 8 ± 6/hour, respectively), effectiveness rating, symptoms, Epworth (12 ± 5 and 8 ± 5, respectively), functional outcomes of sleepiness questionnaire, short-form 36 health survey mental component, and health transition scores. Objective sleepiness, cognitive performance, and preference for treatments were not different. In patients experiencing a mild form of the syndrome (AHI < 15, n = 18), symptoms, treatment efficacy and satisfaction, and subjective sleepiness were also better with CPAP than with MRS (effect sizes, 0.7–1.1 SDs). These results do not support these MRS devices as first-line treatment for sleepy patients with SAHS.

Key Words: positive pressure ventilation • intraoral device • sleep apnea syndromes • randomized controlled trial

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