Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet Before and After Treatment With a Mandibular Advancement Device (MAD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Pulse Average
研究概览
简要总结
This project examines sleep (e.g. prevalence of obstructive sleep apnea(OSA)), dimension of upper airway, jaw function, well-being and quality of life in children with large overjet compared to a control group. In addition, the effect of treatment with a mandibular advancement device (MAD) on sleep, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.
详细描述
Sleep is very important for children's growth, development and learning. The anatomy and size of the airway and position of the jaw can affect children's sleep. Children with large overjet due to a posterior position of the mandible have smaller airways compared to children with neutral occlusion. Reduced dimensions of the upper airways may increase the risk of impaired sleep quality and the sleep related breathing disorder obstructive sleep apnoea (OSA), which causes symptoms e.g. failure to thrive, irritability, behavioural disorders, fatigue, which affects the children's growth, development, and learning negatively.
Children with large overjet due to mandibular retrognathia in Denmark are offered orthodontic treatment in municipal dental care and are in most cases treated with a mandibular advancement device (MAD) keeping the mandible in a forward position relative to the maxilla. MADs are also used to treat adults with mild-moderate obstructive sleep apnoea while they sleep. This can reduce the number of apnoea periods by up to 75% as well as preventing daytime sleepiness.
No previous study have examined sleep, upper airway, jaw function, well-being and quality of life in children with large overjet before, during and after MAD treatment compared to a control group with normal occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overjet group:
- •Horizontal maxillary overjet ≥ 6 mm and need of orthodontic treatment according to the Danish procedure for screening the child population for malocclusion involving health risk.
- •Informed consent from parent(s)/guardian(s)
- •Control group:
- •Neutral occlusion
- •No history of orthodontic treatment
- •Informed consent from parent(s)/guardian(s)
排除标准
- •Known general and/or craniofacial syndromes/diseases
- •Known sleep disorders, included bruxism during sleep
- •Chronic respiratory diseases and asthma6/12
- •Adenoid vegetations, hypertrophic tonsils and significantly reduces airflow through the nose (mouth breather), which need primary treatment.
- •Dysfunction of masticatory muscles and temporomandibular joint, which need primary treatment.
研究组 & 干预措施
Children with large overjet
Overjet ≥6 mm, planned orthodontic treatment with functional appliance
干预措施: Orthodontic treatment with functional appliance (MAD) (Device)
Control group
Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment
结局指标
主要结局
Pulse Average
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Berlin questionnaire
时间窗: 14-18 months from baseline (after z-activator (MAD))
The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2. Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Estimated sleep efficiency %
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed. Estimated sleep efficiency % = Total Sleep Time / Total Time in bed. ≥80 % is considered good/normal
Presence and grade of obstructive sleep apnea
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Apnea: Reduction of ≥ 90 % of the oronasal airflow compared to baseline lasting for more than two breaths' duration. Hypopnea: Reduction of oronasal airflow of ≥ 30 % compared to baseline; desaturation of blood oxygen of ≥ 3% lasting for more than two breaths' duration, or association of desaturation with an arousal. Apnea-hypopnea pr hour during sleep (AHI-index) Normal: AHI \<1; mild: AHI\>1; moderate: AHI\>5; severe: AHI\>10
Oxygen desaturation index (ODI)
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI\<1 is considered normal.
Snore Index
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
SpO2 under 90 %
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Respiration rate
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (\<12 years)
Average SpO2%
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Oximeter quality %
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Respiratory inductance plethysmography (RIP) quality %
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
Flow quality %
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Lowest SpO2%
时间窗: 14-18 months from baseline (after z-activator (MAD))
Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
时间窗: 14-18 months from baseline (after z-activator (MAD))
ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep. Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.
次要结局
- Acoustic rhinometry(14-18 months from baseline (after z-activator (MAD)))
- Acoustic pharyngometry(14-18 months from baseline (after z-activator (MAD)))
- Cephalometric x-ray(14-18 months from baseline (after z-activator (MAD)))
- Cone-Beam Computed Tomography(14-18 months from baseline (after z-activator (MAD)))
研究者
Camilla Hansen
PhD student
University of Copenhagen