Generic Portal

TY - JOUR

T1 - Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea

AU - Bosschieter, Pien F. N.

AU - Uniken Venema, Julia A. M.

AU - Vonk, Patty E.

AU - Ravesloot, Madeline J. L.

AU - Hoekema, Aarnoud

AU - Plooij, Joanneke M.

AU - Lobbezoo, Frank

AU - de Vries, Nico

N1 - Funding Information: All authors have seen and approved the manuscript. Work for this study was supported by Airway Management Inc. The funding was distributed by the Academic Center Dentistry Amsterdam (ACTA) as an independent party over several cost items. Dr. A. Hoekema is medical advisor for Airway Management Inc, SomnoMed, and Zephyr Sleep Technologies. Prof. Dr. F. Lobbezoo receives research grants from Sunstar Suisse SA, SomnoMed, and Vivisol-ResMed and is an unpaid member of the academic advisory boards for GrindCare and for Oral Function (Sunstar Suisse SA). Prof. Dr. N. de Vries is a member of the Medical Advisory Board of NightBalance and consultant for Philips Healthcare, Inspire Medical Systems, and Nyxoah. The other authors report no conflicts of interest. Publisher Copyright: Copyright 2022 American Academy of Sleep Medicine. All rights reserved.

PY - 2022/9/1

Y1 - 2022/9/1

N2 - STUDY OBJECTIVES: Numerous types of mandibular advancement devices (MADs) are available to treat patients with obstructive sleep apnea, varying from noncustom to custom devices. Only a limited number of studies have been performed to determine whether a noncustom MAD could be used to predict treatment success of a custom MAD. In this study, we investigated the potential of a new-generation noncustom MAD, by comparing its effectiveness with a custom MAD. We hypothesized that the effectiveness of the devices is similar with regard to both objective (polysomnography) and self-reported (questionnaires, adherence, and patient satisfaction) outcomes. METHODS: This was a single-center prospective randomized crossover study including a consecutive series of patients with obstructive sleep apnea. Patients were randomized to start either with the noncustom or custom MAD. Both MADs were applied for 12 weeks, followed by polysomnography with MAD in situ and questionnaires. After the first 12 weeks of follow-up, a washout period of 1 week was applied. Equal effectiveness was defined as no significant differences in both objective and self-reported outcomes between both devices. RESULTS: Fifty-eight patients were included; 40 completed the full follow-up. The median apnea-hypopnea index significantly decreased from 16.3 (7.7, 24.8) events/h to 10.7 (5.6, 16.6) events/h with the custom MAD (P = .010) and to 7.8 (2.9, 16.1) events/h with the noncustom MAD (P < .001). Self-reported outcomes significantly improved in both groups. No significant differences were found between both devices. CONCLUSIONS: The effectiveness of a noncustom and custom MAD is comparable, which suggests that a noncustom MAD can be used as a selection tool for MAD treatment eligibility to improve MAD treatment outcome. CLINICAL TRIAL REGISTRATION: Registry: Netherlands Trial Register; Name: The Use of a Boil and Bite Mandibular Advancement Device vs a Custom Mandibular Advancement Device in Obstructive Sleep Apnea Management; URL: https://www.trialregister.nl/trial/7249; Identifier: NL64738.100.18. CITATION: Bosschieter PFN, Uniken Venema JAM, Vonk PE, et al. Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. J Clin Sleep Med. 2022;18(9):2155-2165.

AB - STUDY OBJECTIVES: Numerous types of mandibular advancement devices (MADs) are available to treat patients with obstructive sleep apnea, varying from noncustom to custom devices. Only a limited number of studies have been performed to determine whether a noncustom MAD could be used to predict treatment success of a custom MAD. In this study, we investigated the potential of a new-generation noncustom MAD, by comparing its effectiveness with a custom MAD. We hypothesized that the effectiveness of the devices is similar with regard to both objective (polysomnography) and self-reported (questionnaires, adherence, and patient satisfaction) outcomes. METHODS: This was a single-center prospective randomized crossover study including a consecutive series of patients with obstructive sleep apnea. Patients were randomized to start either with the noncustom or custom MAD. Both MADs were applied for 12 weeks, followed by polysomnography with MAD in situ and questionnaires. After the first 12 weeks of follow-up, a washout period of 1 week was applied. Equal effectiveness was defined as no significant differences in both objective and self-reported outcomes between both devices. RESULTS: Fifty-eight patients were included; 40 completed the full follow-up. The median apnea-hypopnea index significantly decreased from 16.3 (7.7, 24.8) events/h to 10.7 (5.6, 16.6) events/h with the custom MAD (P = .010) and to 7.8 (2.9, 16.1) events/h with the noncustom MAD (P < .001). Self-reported outcomes significantly improved in both groups. No significant differences were found between both devices. CONCLUSIONS: The effectiveness of a noncustom and custom MAD is comparable, which suggests that a noncustom MAD can be used as a selection tool for MAD treatment eligibility to improve MAD treatment outcome. CLINICAL TRIAL REGISTRATION: Registry: Netherlands Trial Register; Name: The Use of a Boil and Bite Mandibular Advancement Device vs a Custom Mandibular Advancement Device in Obstructive Sleep Apnea Management; URL: https://www.trialregister.nl/trial/7249; Identifier: NL64738.100.18. CITATION: Bosschieter PFN, Uniken Venema JAM, Vonk PE, et al. Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. J Clin Sleep Med. 2022;18(9):2155-2165.

KW - drug-induced sleep endoscopy

KW - mandibular advancement device

KW - obstructive sleep apnea

KW - sleep-disordered breathing

KW - treatment success

UR - http://www.scopus.com/inward/record.url?scp=85135745278&partnerID=8YFLogxK

U2 - 10.5664/jcsm.10058

DO - 10.5664/jcsm.10058

M3 - Article

C2 - 35532113

VL - 18

SP - 2155

EP - 2165

JO - Journal of clinical sleep medicine : JCSM

JF - Journal of clinical sleep medicine : JCSM

SN - 1550-9389

IS - 9

ER -