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.
| NCT ID | NCT04092660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2019-12-06 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2019-12-06 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Insufficient teeth for MAA fabrication * Poor dental and/or periodontal health * Symptomatic Temporomandibular Disorder (TMD) * Previously used an MAA * Patients with Epilepsy
Contact & Investigator
Ama Johal
STUDY CHAIR
Queen Mary University of London
Frequently Asked Questions
Who can join the NCT04092660 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04092660 currently recruiting?
Yes, NCT04092660 is actively recruiting participants. Contact the research team at a.s.johal@qmul.ac.uk for enrollment information.
Where is the NCT04092660 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04092660 clinical trial?
NCT04092660 is sponsored by Queen Mary University of London. The principal investigator is Ama Johal at Queen Mary University of London. The trial plans to enroll 56 participants.