title: Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnoea syndrome: a randomised, placebo-controlled trial on self-reported symptoms of common sleep disorders and sleep-related problems.
abstract: Obstructive sleep apnoea syndrome (OSAS) is associated with several sleep disorders and sleep-related problems. Therefore, the aim of this study was to compare the effects of a mandibular advancement device (MAD) with those of nasal continuous positive airway pressure (nCPAP) on self-reported symptoms of common sleep disorders and sleep-related problems in mild and moderate OSAS patients. In this randomised placebo-controlled trial, sixty-four OSAS patients (52·0 ± 9·6 years) were randomly assigned to an MAD, nCPAP or an intra-oral placebo appliance in a parallel design. All participants filled out the validated Dutch Sleep Disorders Questionnaire (SDQ) twice: one before treatment and one after six months of treatment. With 88 questions, thirteen scales were constructed, representing common sleep disorders and sleep-related problems. Linear mixed model analyses were performed to study differences between the groups for the different SDQ scales over time. The MAD group showed significant improvements over time in symptoms corresponding with 'insomnia', 'excessive daytime sleepiness', 'psychiatric sleep disorder', 'periodic limb movements', 'sleep apnoea', 'sleep paralysis', 'daytime dysfunction', 'hypnagogic hallucinations/dreaming', 'restless sleep', 'negative conditioning' and 'automatic behaviour' (range of P values: 0·000-0·014). These improvements in symptoms were, however, not significantly different from the improvements in symptoms observed in the nCPAP and placebo groups (range of P values: 0·090-0·897). It can be concluded that there is no significant difference between MAD and nCPAP in their positive effects on self-reported symptoms of common sleep disorders and sleep-related problems in mild and moderate OSAS patients. These beneficial effects may be a result of placebo effects.
authors.affiliation: Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), MOVE Research Institute Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Nikolopoulou
authors.affiliation: Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), MOVE Research Institute Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Byraki
authors.affiliation: Department of Oral and Maxillofacial Diseases, University of Helsinki, Helsinki, Finland.
authors.forename: J
authors.initials: J
authors.lastname: Ahlberg
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center Amsterdam, Amsterdam, The Netherlands.
authors.forename: M W
authors.initials: MW
authors.lastname: Heymans
authors.affiliation: Amsterdam Sleep Centre, Boerhaave Medical Centre, Amsterdam, The Netherlands.
authors.forename: H L
authors.initials: HL
authors.lastname: Hamburger
authors.affiliation: Department of Oral and Maxillofacial Surgery, Academic Medical Centre of the University of Amsterdam and Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: De Lange
authors.affiliation: Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), MOVE Research Institute Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Lobbezoo
authors.affiliation: Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), MOVE Research Institute Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: G
authors.identifier: http://orcid.org/0000-0002-6677-7897
authors.initials: G
authors.lastname: Aarab
mesh_terms: D000328:Adult; D045422:Continuous Positive Airway Pressure; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000295:instrumentation; D008875:Middle Aged; D009426:Netherlands; D017286:Polysomnography; D057566:Self Report; D020181:Sleep Apnea, Obstructive / Q000150:complications* / Q000503:physiopathology / Q000628:therapy*; D012893:Sleep Wake Disorders / Q000150:complications* / Q000503:physiopathology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: continuous positive airway pressure; mandibular advancement; obstructive sleep apnoea; placebo; randomised controlled trial; sleep-wake disorders