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.

NCT04092660 | Recruiting

• 1 other identifier: 262092
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night

  the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.

  3 months

• Adherence-the number of hours the patient uses the MAA or anti-snoring mouth guard

  the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.

  6 month

Secondary Outcomes (6)

• Self-efficacy, risk perception, outcome expectancy

  Initial screening, 3 and 6 month

• Socio-economic status

  Initial Screening

• Social support

  Initial Screening

• Sleep Quality

  Initial Screening and 6 month

• Sleepiness Score: How likely is the participant to fall asleep in certain situations?

  Initial Screening and 6 month

Study Arms (2)

Intervention Care Group

EXPERIMENTAL

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.

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

Standardized Care Group

ACTIVE COMPARATOR

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.

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

Interventions

Behaviour change Intervention Based on Health Action Process Approach Model BEHAVIORAL

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

Intervention Care Group

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

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.

Intervention Care Group; Standardized Care Group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Royal London Dental Hospital

London, E1 2AD, United Kingdom

RECRUITING

Related Publications (1)

• Tallamraju H, Newton JT, Fleming PS, Johal A. Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial. Trials. 2021 Oct 13;22(1):699. doi: 10.1186/s13063-021-05582-1.

  PMID: 34645490 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ama Johal

  Queen Mary University of London

  STUDY CHAIR

Central Study Contacts

Ama Johal

CONTACT

0207 377 7686; a.s.johal@qmul.ac.uk

Harishri Tallamraju

CONTACT

07788128535; h.tallamraju@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre Randomized Control Trial

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: December 6, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)