Actively Recruiting

Phase Not Applicable
Age: 40Years - 90Years
All Genders
NCT04092660

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.

Led by Queen Mary University of London · Updated on 2026-05-06

56

Participants Needed

1

Research Sites

338 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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.

Who Can Participate

Age: 40Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult 40 years or older
  • Confirmed diagnosis of obstructive sleep apnea with apnea-hypopnea index of 5 or higher
  • Referred for mandibular advancement appliance therapy
  • Able to understand, read, and write English with or without translator assistance
Not Eligible

You will not qualify if you...

  • Not enough teeth to make the mandibular advancement appliance
  • Poor dental or gum health
  • Symptomatic temporomandibular disorder (TMD)
  • Previously used a mandibular advancement appliance
  • History of epilepsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Royal London Dental Hospital

London, United Kingdom, E1 2AD

Actively Recruiting

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Research Team

A

Ama Johal

CONTACT

H

Harishri Tallamraju

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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