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临床试验/NCT06330116
NCT06330116Enrolling By Invitation不适用

A Comparison of Three Different Forms of Oral Myofunctional Training (OMT) as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea

Region Västerbotten6 个研究点 分布在 2 个国家目标入组 141 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
141
试验地点
6
主要终点
Apnea-hypopnea index (AHI)

研究概览

简要总结

Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements.

Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro® or serving as controls. Participants in Köge will be randomized to either training with Exciteosa®, group training, or controls.

The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings.

The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment.

详细描述

Introduction/Background

Snoring and obstructive sleep apnea (OSA) are common among the adult population; a mean of 22% and 17% of the women are affected. Obstructive sleep apnea is related to several negative health effects, such as sleepiness, hypertension, cardiovascular disease, and cognitive impairment. Continuous positive airway pressure (CPAP), oral appliances (OA), as well as oropharyngeal surgery in selected cases are available as a treatment for OSA. The same methods can be used for reducing snoring, but the cost for the devices is high, and the compliance tends to be low, although snoring affects the individual as well as the bed partner. Snoring produces vibrations in the upper airway, and over time, it can affect both the motor and sensory function of the tissue in the upper airway. The deterioration process is unknown, but previously published data shows a correlation between the level of snoring/OSA and altered sensory and motor function. This is probably due to the adverse effects of the vibrations and stretching of the nerves and muscles in the airway during snoring and apneas. Our and other research groups have presented similar results and hypothesize that the deterioration may explain why the airway slowly tends to collapse more frequently. This may also explain why more than half of the habitual snorers show deviant swallowing function and thereby have a higher risk of aspiration. It is unknown if this degenerative process of the upper airway is possible to slow down, stop or perhaps even be reversed and thereby improve the sensory and motor function by treatment that decrease or determine snoring and OSA. However, recent data give promising indications that myofunctional training of the upper airway can decrease levels and intensity of snoring and reduce the apnea-hypopnea index (AHI).

Oral screen training can affect brain plasticity and have a strengthening effect on oral and pharyngeal muscles. Oral screen training is used to improve oral and pharyngeal muscle function and has been reported to improve swallowing function in patients suffering from dysphagia including aspiration after stroke. Further, it has been reported to be efficient for the treatment of dysphagia caused by other conditions.

Daily neuromuscular electrical training (NMES) by an oral device eXciteosa® has shown promising results in patients with primary snoring and mild sleep apnea, reducing objective and subjective snoring. Orofacial training guided by an occupational therapist (group training) has also shown positive results in adhering to the training program and affecting the AHI, reducing it in persons aged 60 and younger.

The aim of the present study is, therefore, to assess 1) the impact of three different training methods to reduce AHI among adults with mild to moderate sleep apnea and 2) if the oral screen training can lower the level and intensity of snoring, change levels of sleepiness, quality of life and strength of the tongue muscle.

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

The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase and follow-up measurements, and controls without intervention. The results are then analyzed and blinded to the evaluators.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women with AHI 10 - 29 seeking for problems with snoring and obstructive sleep apnea, age 18 to 75.

排除标准

  • Subjects with previous surgery of the soft palate, 9 < AHI > 29, smokers, New York Heart Association Functional Classification, NYHA ≥
  • BMI >34,9.

研究组 & 干预措施

Group training with an occupational therapist

Active Comparator

Strength training of the oral and pharyngeal muscles is performed in group, led by an occupational therapist. Training for 3 months.

干预措施: Grouptraining (Behavioral)

Oral screen

Active Comparator

Strength training of the oral and pharyngeal muscles is performed with an oral screen (OS)(IQoro). The OS is a device that has an effect both on the brain plasticity and a strengthening effect of oral and pharyngeal muscles. (9) The OS is placed pre-dentally behind closed lips. The patient pulls the OS forward in a horizontal direction with strong pressure for 5 to 10 seconds while firmly resisting the pressure with tightened lips. The exercise is repeated three times, with 3 seconds of rest between repetitions, and is performed 3 times per day. Training for 3 months.

干预措施: IQoro (Device)

Neuromuscular electrical training (NMES)

Active Comparator

Strength training of the oral and pharyngeal muscles is performed by an oral device used for 20 minutes every day (eXciteosa). The device gives electrical pulses to the surrounding tissue, mainly the tongue. Training for 3 months.

干预措施: eXciteosa (Device)

结局指标

主要结局

Apnea-hypopnea index (AHI)

时间窗: 90 days. Between first measurement (inclusion in study at baseline) and second measurement (at follow-up after 90 days of intervention or serving as control)

The primary outcome is the change in the apnea-hypopnea index (AHI) before and after three months of intervention or control. months of training with one of the modalities, according to two overnight ambulatory sleep apnea recordings.

次要结局

  • Questionnaires(90 days. Between first measurement (inclusion in study at baseline) and second measurement (at follow-up after 90 days of intervention or serving as control))
  • Snoring(90 days. Between first measurement (inclusion in study at baseline) and second measurement (at follow-up after 90 days of intervention or serving as control))
  • Tounge strength(90 days. Between first measurement (inclusion in study at baseline) and second measurement (at follow-up after 90 days of intervention or serving as control))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (6)

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