Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night
研究概览
简要总结
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.
详细描述
The present study aims to assess whether special support approaches i.e. Interventions influence patients with Obstructive sleep apnoea (OSA), to use the Mandibular Advancement Appliance (MAA) or the anti-snoring mouth guard, more as compared to those who receive standard care.
Factors such as mood, anxiety, stress, depression, socioeconomic status, and social support play an important role in the ability of the patients to make decisions about using the appliance. Thus, the investigators also aim to explore the potential role these factors play in the decision-making process to help future patients make most of their treatments.
Patients meeting the selection criteria will be provided with a patient information leaflet, explaining the whole study. Interested patients will be asked to sign the Informed Consent, after which they will be randomly assigned into two groups- Intervention Care group (IC) and Standardized Care group (SCG).
Patients will be provided with a sleep diary to record their hours of sleep and usage of MAA, which will give a subjective record of the adherence (duration of usage of MAA) and an objective record of the adherence will be collected from a sensor present in the MAA.
At Initial Screening, the patient's age, gender, body mass index (BMI) and neck circumference will be recorded. Patients in the IC group will receive a Health Pamphlet about OSA, specially designed for this study. The IC group's knowledge of OSA will be assessed along with their partner's. Patients in the IC group will be shown a 10 min video highlighting the negative impact of OSA. While patients in the SC group will only be provided with a pamphlet about OSA and MAA as per standard routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Insufficient teeth for MAA fabrication
- •Poor dental and/or periodontal health
- •Symptomatic Temporomandibular Disorder (TMD)
- •Previously used an MAA
- •Patients with Epilepsy
研究组 & 干预措施
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.
干预措施: Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard (Device)
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.
干预措施: Behaviour change Intervention Based on Health Action Process Approach Model (Behavioral)
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.
干预措施: Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard (Device)
结局指标
主要结局
Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night
时间窗: 3 months
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.
Adherence-the number of hours the patient uses the MAA or anti-snoring mouth guard
时间窗: 6 month
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.
次要结局
- Social support(Initial Screening)
- Health related Quality of Life(Initial Screening and 6 month)
- Self-efficacy, risk perception, outcome expectancy(Initial screening, 3 and 6 month)
- Socio-economic status(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)