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Extra support to help people with obstructive sleep apnoea use their mouth guard

Tests added support for using a mouth guard in adults with obstructive sleep apnoea.

Key facts

Who runs it
Queen Mary University of London
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Registry 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.
Status
Recruiting
People taking part
56 people, planned
Started
6 Dec 2019
Planned end
1 Jun 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Behaviour change Intervention Based on Health Action Process Approach Model
  • Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard
Record updated
6 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 or older with obstructive sleep apnoea who have been referred for a mouth guard that holds the lower jaw forward (MAA). It tests whether extra support helps people wear it more.

Age
40 Years to 90 Years
Sex
All sexes can join.
Disease stage
Confirmed obstructive sleep apnoea, with an apnoea-hypopnoea index (AHI, breathing pauses per hour of sleep) of 5 or more.
Earlier treatment
People must be referred for MAA therapy. People who have used an MAA before cannot join.
Biomarker or test result
AHI ≥ 5 on a sleep study.

Main reasons for not taking part

  • Not enough teeth to make the MAA
  • Poor health of the teeth or gums
  • Jaw joint problems that cause symptoms (Temporomandibular Disorder)
  • Previous use of an MAA
  • Epilepsy

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Adult (≥ 40 years old)
  • Confirmed diagnosis of OSA (AHI ≥ 5)
  • Referred for MAA therapy
  • Must be able to understand, read and write English; with the assistance of a translator

Who cannot take part

  • Previously used an MAA
  • Symptomatic Temporomandibular Disorder (TMD)
  • Patients with Epilepsy
  • Insufficient teeth for MAA fabrication
  • Poor dental and/or periodontal health

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 90 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Intervention Care GroupTreatment being tested

    The Intervention care group will receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard. Additionally, they will also receive special support in the form of behaviour change interventions. The behavior change interventions consist of motivational interviewing, will be shown a video highlighting the negative consequences of sleep apnoea. Booster calls at week 3,6, 18 and 12 for verbal encouragement and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life.

    Treatment: Behaviour change Intervention Based on Health Action Process Approach Model and Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard

  • Standardized Care GroupExisting treatment, for comparison

    The standardized care group will only receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard along with routine care and will be called for follow up at 3rd and 6th month of treatment to assess their use and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life at the initial visit and subsequent follow-up.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
Plain-language title
Extra support to help people with obstructive sleep apnoea use their mouth guardGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT04092660, who can take part
Publications
Record updated
6 May 2026