Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint.
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] >or= 5/hour, and >or= 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 <or= 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.
Engleman
Heather M
HM
Edinburgh Sleep Centre, Respiratory Medicine Unit, University of Edinburgh, Edinburgh, UK. h.engleman@ed.ac.uk
McDonald
James P
JP
Graham
David
D
Lello
Glenn E
GE
Kingshott
Ruth N
RN
Coleman
Emma L
EL
Mackay
Thomas W
TW
Douglas
Neil J
NJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D003071:Cognition; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008334:Mandible; D008875:Middle Aged; D010045:Outpatients; D017060:Patient Satisfaction; D017286:Polysomnography; D011175:Positive-Pressure Respiration; D012890:Sleep; D012891:Sleep Apnea Syndromes / Q000628:therapy*; D013165:Splints / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome