TY - JOUR
T1 - Single-centre, single-blinded, randomised, parallel group, feasibility study protocol investigating if mandibular advancement device treatment for obstructive sleep apnoea can reduce nocturnal gastro-oesophageal reflux (MAD-Reflux trial)
AU - O'Toole, Saoirse
AU - Moazzez, Rebecca
AU - Wojewodka, Gabriella
AU - Zeki, Sebastian
AU - Jafari, Jafar
AU - Hope, Katherine
AU - Brand, Andrew
AU - Hoare, Zoe
AU - Scott, Suzanne
AU - Doungsong, Kodchawan
AU - Ezeofor, Victory
AU - Edwards, Rhiannon Tudor
AU - Drakatos, Panagis
AU - Steier, Joerg
N1 - Funding Information:
This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR202744). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. This study is sponsored by Guy’s and St Thomas’s Trust and King’s College London. The funder and sponsor did not have any authority over the intellectual development and decision to submit this paper for publication.
Funding Information:
This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR202744). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. This study is sponsored by Guy's and St Thomas's Trust and King's College London. The funder and sponsor did not have any authority over the intellectual development and decision to submit this paper for publication.
Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/8/24
Y1 - 2023/8/24
N2 - INTRODUCTION: Just under half of patients with obstructive sleep apnoea (OSA) also have gastro-oesophageal reflux disease (GORD). These conditions appear to be inter-related and continual positive airway pressure (CPAP) therapy, the gold standard treatment for OSA to prevent airway collapse, has been shown to reduce GORD. As the impact of mandibular advancement devices, a second-line therapy for OSA, on GORD has yet to be investigated, a feasibility study is needed prior to a definitive trial.METHODS: This will be a single-centre, single-blinded, tertiary-care based, interdisciplinary, parallel randomised controlled study. Potential OSA participants presenting to the sleep department will be pre-screened for GORD using validated questionnaires, consented and invited to receive simultaneous home sleep and oesophageal pH monitoring. Those with confirmed OSA and GORD (n=44) will be randomly allocated to receive either CPAP (n=22) or MAD therapy (n=22). Following successful titration and 3 weeks customisation period, participants will repeat the simultaneous sleep and oesophageal pH monitoring while wearing the device. The number of patients screened for recruitment, drop-out rates, patient feedback of the study protocol, costs of interventions and clinical information to inform a definitive study design will be investigated.ETHICS AND DISSEMINATION: Health Research Authority approval has been obtained from the Nottingham 2 Research Ethics Committee, ref:22/EM/0157 and the trial has been registered on ISRCTN (https://doi.org/10.1186/ISRCTN16013232). Definitive findings about the feasibility of doing 24 hour pH oesophageal monitoring while doing a home sleep study will be disseminated via clinical and research networks facilitating valuable insights into the simultaneous management of both conditions.TRIAL REGISTRATION NUMBER: ISRCTN Reg No: 16013232.
AB - INTRODUCTION: Just under half of patients with obstructive sleep apnoea (OSA) also have gastro-oesophageal reflux disease (GORD). These conditions appear to be inter-related and continual positive airway pressure (CPAP) therapy, the gold standard treatment for OSA to prevent airway collapse, has been shown to reduce GORD. As the impact of mandibular advancement devices, a second-line therapy for OSA, on GORD has yet to be investigated, a feasibility study is needed prior to a definitive trial.METHODS: This will be a single-centre, single-blinded, tertiary-care based, interdisciplinary, parallel randomised controlled study. Potential OSA participants presenting to the sleep department will be pre-screened for GORD using validated questionnaires, consented and invited to receive simultaneous home sleep and oesophageal pH monitoring. Those with confirmed OSA and GORD (n=44) will be randomly allocated to receive either CPAP (n=22) or MAD therapy (n=22). Following successful titration and 3 weeks customisation period, participants will repeat the simultaneous sleep and oesophageal pH monitoring while wearing the device. The number of patients screened for recruitment, drop-out rates, patient feedback of the study protocol, costs of interventions and clinical information to inform a definitive study design will be investigated.ETHICS AND DISSEMINATION: Health Research Authority approval has been obtained from the Nottingham 2 Research Ethics Committee, ref:22/EM/0157 and the trial has been registered on ISRCTN (https://doi.org/10.1186/ISRCTN16013232). Definitive findings about the feasibility of doing 24 hour pH oesophageal monitoring while doing a home sleep study will be disseminated via clinical and research networks facilitating valuable insights into the simultaneous management of both conditions.TRIAL REGISTRATION NUMBER: ISRCTN Reg No: 16013232.
KW - Feasibility Studies
KW - GASTROENTEROLOGY
KW - Health economics
KW - ORAL MEDICINE
KW - SLEEP MEDICINE
UR - http://www.scopus.com/inward/record.url?scp=85168728804&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-076661
DO - 10.1136/bmjopen-2023-076661
M3 - Article
C2 - 37620257
AN - SCOPUS:85168728804
SN - 2044-6055
VL - 13
SP - e076661
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e076661
ER -