Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.

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.

The investigators 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, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and/or prevents their adherence.

Conditions

• Obstructive Sleep Apnea

Interventions

BEHAVIORAL

Behaviour change Intervention Based on Health Action Process Approach Model

The Behaviour change intervention based on the Health Action Process Approach model entails delivering interventions in a staged manner. Following are the intervention that will be delivered along with the time point of the delivery. 1. Health Pamphlet at the initial screening 2. Sleep Apnoea video highlighting the negative consequences at the day of the fitting of the appliance 3. Counseling involving motivational interviewing for both the participant and the participant's partner at the day of fitting of the appliance and follow up visits. 4. Booster phone calls in between the follow-up visits

DEVICE

Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard

Patients with mild-to-moderate sleep apnoea are treated with Mandibular Advancement Appliances \[MAA\] also known as Anti-snoring mouth guards or Oral appliances. These are best made to fit and use the teeth to hold them in place during sleep. They work by moving (in a gradual fashion) the bottom jaw forward, opening the airway at the back of the throat. Both the arms- Intervention arm and Standardized arm will be given the anti-snoring mouth guard. The usage of the device will be measured subjectively by providing a sleep diary to the participants to record the hour of the usage and objectively by downloading the data from a micro sensor chip embedded in the device.

Sponsors & Collaborators

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Ama Johal · Queen Mary University of London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-06

Primary Completion

2026-06-01

Completion

2026-06-01

Countries

• United Kingdom

Study Locations