Effects of myTAP Oral Appliance Therapy on Cardio-respiratory Dynamics in Mouth-breathers Who Snore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Respiratory Event Index (REI) at T2
研究概览
简要总结
Breathing is one of the body's vital functions that occur under normal conditions using the nose. When humans breathe primarily through the mouth instead of the nose, this is referred to as mouth breathing. Snoring and obstructive sleep apnea (OSA) occur frequently in mouth breathers. Mouth breathing impairs oral health, reduces quantity and quality of saliva, and increases dry mouth, risk of developing dental caries, gingival inflammation, bad breath and dry lips. Serious health conditions associated with an obstructed upper airway in those who snore include hypertension, cardiovascular disease and mild cognitive impairment.
Oral appliances (OAs) that bring the lower jaw (mandible) forward have been shown to be highly effective in reducing snoring and interruptions in breathing (respiratory events) that occur in those who snore and/or have OSA. The myTAP™ OA (AMI, Dallas, TX) includes an optional mouth shield (MS) that is anticipated to promote nasal breathing. The purpose of this study is to investigate the effects of oral appliance plus mouth shield therapy on sleep cardio-respiratory dynamics (breathing and heart activity) and their effect on improving OSA and oral health, especially of the periodontal tissues, in confirmed mouth breathers who snore and/or have OSA. As many as 70 adults at least 18 years old will be recruited to participate.
All participants will wear the OA during sleep for 8 weeks (Phase 1). Half of the participants will be randomly assigned to wear the OA only for the first 4 weeks; all will wear both the OA and MS for the last 4 weeks. Participants will wear an easy-to-use home sleep recording system (NOX T3) for 2 nights at the start of the study and again at 4 weeks and 8 weeks. Based on the investigators' experience, some participants will not have achieved maximal benefit from the OA at 8 weeks, and will require addition adjustment. These participants will enter a second phase of the study where they will have 1 or more sleep studies done at 2 week intervals, and will further adjust their OAs (that is, advance the mandible) to eliminate snoring.
详细描述
Background: Respiration is one of the body's vital functions that occurs under normal conditions using the nose. When nasal breathing is supplemented by or supplanted through the mouth, this is referred to as mouth breathing. Primary snoring and obstructive sleep apnea (OSA) are frequent findings in mouth breathers, regardless of age. In children, mouth breathing is often associated with enlarged adenoids and tonsils, changes in body posture, hyperactivity, attention deficit and impaired learning. In all ages, mouth breathing impairs oral health, reduces quantity and quality of saliva, and increases dry mouth, risk of developing dental caries, gingival inflammation, bad breath and dry lips. Symptoms associated with an obstructed upper airway in those who snore include hypertension, cardiovascular disease and mild cognitive impairment. There are currently no data on the effects of oral appliance plus mouth shield therapy on sleep cardio-respiratory dynamics and their effect on improving OSA and oral health, especially periodontal health, in mouth breathers.
Methods: Evaluation of the effects of the FDA cleared MyTAP midline traction type oral appliance (OA; AMI, Dallas, TX) in combination with its FDA-cleared mouth shield (MS) in treating confirmed mouth breathers who snore and/or have OSA.
Power analysis: Sample size (n=40) is based on a-posteriori power of 80% observed in the investigative team's recently completed randomized controlled trial (RCT) comparing two OA designs. As many as 70 participants will be enrolled to account for drop-outs.
Design: Single center, prospective randomized clinical trial using a parallel group design.
Randomization: Using an online randomizer software, half of the subjects will be assigned to Group "OA plus MS 8wk", OA use with MS for 8-weeks and group "OA Alone 4wk" (no MS) for first 4-weeks. The OA Alone 4wk group will add MS use after 4-weeks and continue to use the combination for subsequent 4-weeks.
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
- Single (Outcomes Assessor)
盲法说明
Investigators scoring sleep studies and doing data analysis will be blinded with regard to group identity.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Unable or unwilling to complete the study demands & schedule.
- •Active temporomandibular joint dysfunction (TMD) or jaw muscle pain, morphological airway abnormalities.
- •Severe restrictions in jaw opening.
- •Pre-existing difficulty swallowing; throat or neck related health issues; unmanaged endocrine dysfunction.
- •Severe chronic nasal obstruction that precludes possibility of nasal breathing.
- •Severe psychiatric & neurological disorders; intellectually disabled.
- •Advanced periodontal disease (e.g., loose teeth).
- •History of uvulopalatopharyngoplasty (UPPP) surgery.
- •Loose teeth, loose crowns or fillings.
- •Removable dentures or bridges.
- •Temporary crowns.
- •Orthodontic braces.
- •Other oral conditions which would be adversely affected by wearing dental appliances.
结局指标
主要结局
Respiratory Event Index (REI) at T2
时间窗: 4 weeks
Number of apneas and hypopneas per hour of recording using the NOX T3 sleep recording system at T2 (4 weeks). REI is reported instead of Apnea Hypopnea Index (AHI), as it is a more appropriate measure for home sleep testing. Apneas are scored when there is a 90% drop in the flow signal between 10 and 120 seconds. Hypopneas are scored when there is a 30% drop in flow signal between 10 and 120 seconds followed by either a drop in oxygen saturation or an arousal.
次要结局
未报告次要终点
研究者
Emet D. Schneiderman, PhD
Professor
Texas A&M University