Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Royal London Dental Hospital
RECRUITING
London
Contact Information
Primary
Ama Johal
a.s.johal@qmul.ac.uk
0207 377 7686
Backup
Harishri Tallamraju
h.tallamraju@qmul.ac.uk
07788128535
Time Frame
Start Date: 2019-12-06
Estimated Completion Date: 2026-03
Participants
Target number of participants: 56
Treatments
Experimental: Intervention Care Group
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.
Active_comparator: Standardized Care Group
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.
Related Therapeutic Areas
Sponsors
Leads: Queen Mary University of London

This content was sourced from clinicaltrials.gov