Ama Johal1, Priya Haria1, Seema Manek1, Easter Joury1, Renata Riha2. 1. Oral Growth and Development, Institute of Dentistry, Queen Mary University of London, UK. 2. Sleep and Respiratory Medicine, Edinburgh Royal infirmary, UK.
Abstract
STUDY OBJECTIVES: To compare the effectiveness of a custom-made (MRDc) versus ready-made (MRDr) mandibular repositioning devices (MRD) in the management of obstructive sleep apnea (OSA). METHODS: A randomized crossover trial design was adopted in which patients with a confirmed diagnosis of OSA were randomly allocated to receive either a 3-month period of ready-made or custom-made MRD, with an intervening washout period of 2 weeks, prior to crossover. Treatment outcomes included both objective sleep monitoring and patient-centered measures (daytime sleepiness, partner snoring and quality of life). RESULTS:Twenty-five patients, with a mild degree of OSA (apnea-hypopnea index of 13.3 [10.9-25] events/h) and daytime sleepiness (Epworth Sleepiness Scale of 11 [6-16]), completed both arms of the trial. The MRDc achieved a complete treatment response in 64% of participants, compared with 24% with the MRDr (p < 0.001). A significant difference was observed in treatment failures, when comparing the MRDr (36%) with the MRDc (4%). Excessive daytime sleepiness (Epworth Sleepiness Scale ≥ 10) persisted in 33% (MRDc) and 66% (MRDr) of OSA subjects, following treatment. A statistically significant improvement was observed in quality of life scales following MRDc therapy only. Significant differences were observed in relation to both the number of nights per week (p = 0.004) and hours per night (p = 0.006) between the two different designs of device. CONCLUSIONS: The study demonstrates the significant clinical effectiveness of a custom-made mandibular repositioning device, particularly in terms of patient compliance and tolerance, in the treatment of OSA.
RCT Entities:
STUDY OBJECTIVES: To compare the effectiveness of a custom-made (MRDc) versus ready-made (MRDr) mandibular repositioning devices (MRD) in the management of obstructive sleep apnea (OSA). METHODS: A randomized crossover trial design was adopted in which patients with a confirmed diagnosis of OSA were randomly allocated to receive either a 3-month period of ready-made or custom-made MRD, with an intervening washout period of 2 weeks, prior to crossover. Treatment outcomes included both objective sleep monitoring and patient-centered measures (daytime sleepiness, partner snoring and quality of life). RESULTS: Twenty-five patients, with a mild degree of OSA (apnea-hypopnea index of 13.3 [10.9-25] events/h) and daytime sleepiness (Epworth Sleepiness Scale of 11 [6-16]), completed both arms of the trial. The MRDc achieved a complete treatment response in 64% of participants, compared with 24% with the MRDr (p < 0.001). A significant difference was observed in treatment failures, when comparing the MRDr (36%) with the MRDc (4%). Excessive daytime sleepiness (Epworth Sleepiness Scale ≥ 10) persisted in 33% (MRDc) and 66% (MRDr) of OSA subjects, following treatment. A statistically significant improvement was observed in quality of life scales following MRDc therapy only. Significant differences were observed in relation to both the number of nights per week (p = 0.004) and hours per night (p = 0.006) between the two different designs of device. CONCLUSIONS: The study demonstrates the significant clinical effectiveness of a custom-made mandibular repositioning device, particularly in terms of patient compliance and tolerance, in the treatment of OSA.
Authors: Olivier M Vanderveken; Annick Devolder; Marie Marklund; An N Boudewyns; Marc J Braem; Walter Okkerse; Johan A Verbraecken; Karl A Franklin; Wilfried A De Backer; Paul H Van de Heyning Journal: Am J Respir Crit Care Med Date: 2007-08-02 Impact factor: 21.405
Authors: T E Weaver; N B Kribbs; A I Pack; L R Kline; D K Chugh; G Maislin; P L Smith; A R Schwartz; N M Schubert; K A Gillen; D F Dinges Journal: Sleep Date: 1997-04 Impact factor: 5.849
Authors: Maree Barnes; R Douglas McEvoy; Siobhan Banks; Natalie Tarquinio; Christopher G Murray; Norman Vowles; Robert J Pierce Journal: Am J Respir Crit Care Med Date: 2004-06-16 Impact factor: 21.405
Authors: Marijke Dieltjens; Marc J Braem; Anneclaire V M T Vroegop; Kristien Wouters; Johan A Verbraecken; Wilfried A De Backer; Paul H Van de Heyning; Olivier M Vanderveken Journal: Chest Date: 2013-11 Impact factor: 9.410
Authors: Sara Op de Beeck; Marijke Dieltjens; Annelies E Verbruggen; Anneclaire V Vroegop; Kristien Wouters; Evert Hamans; Marc Willemen; Johan Verbraecken; Wilfried A De Backer; Paul H Van de Heyning; Marc J Braem; Olivier M Vanderveken Journal: J Clin Sleep Med Date: 2019-08-15 Impact factor: 4.062
Authors: Pien F N Bosschieter; Julia A M Uniken Venema; Patty E Vonk; Madeline J L Ravesloot; Aarnoud Hoekema; Joanneke M Plooij; Frank Lobbezoo; Nico de Vries Journal: J Clin Sleep Med Date: 2022-09-01 Impact factor: 4.324
Authors: Sara Op de Beeck; Marijke Dieltjens; Ali Azarbarzin; Marc Willemen; Johan Verbraecken; Marc J Braem; Andrew Wellman; Scott A Sands; Olivier M Vanderveken Journal: Ann Am Thorac Soc Date: 2021-03