IPOSAT Version 1
Research type
Research Study
Full title
Intervention to enhance adherence to Mandibular advancement appliance in Patients with Obstructive Sleep Apnoea: A Randomized Control Trial
IRAS ID
262092
Contact name
Ama Johal
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient’s acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care.
We also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index >5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA.
Patients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, we also plan to undertake a qualitative one-to-one interviews with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and/or prevents their adherence.Results Summary:
This study looked at whether providing additional behavioural support could help people with obstructive sleep apnoea use their mandibular advancement appliance (a dental device worn during sleep) more regularly.
Fifty-six adults diagnosed with obstructive sleep apnoea took part in the study. Some participants received routine care, while others received additional support designed to improve motivation, confidence, and understanding of treatment.
The results showed that the additional behavioural support did not significantly increase the amount of time participants used their appliance compared to routine care alone. However, participants who better understood the risks of sleep apnoea and the benefits of treatment appeared more likely to use their appliance regularly.
The COVID-19 pandemic affected recruitment and follow-up appointments during the study, which reduced the amount of data available for analysis.
The findings highlight the importance of patient education and psychological factors in supporting long-term use of mandibular advancement appliances in patients with obstructive sleep apnoea.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0391
Date of REC Opinion
19 Aug 2019
REC opinion
Further Information Favourable Opinion