Cervical Stabilization in Individuals With Obstructive Sleep Apnea
Cervical Stabilization in Individuals With Obstructive Sleep Apnea: a Randomized Clinical Trial
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Rio Grande Do Sul
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Santa Maria、Rio Grande Do Sul、巴西、97105-900
- Universidade Federal de Santa Maria
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women aged 20 to 60 years;
- Clinical diagnosis of obstructive apnea of mild, moderate or severe sleep through polysomnography following the apnea / hypopnea index.
Exclusion Criteria:
- Body Mass Index (BMI) greater than or equal to 35 kg / m2;
- Use of continuous positive airway pressure;
- Diagnosis of neurological or neuromuscular disease;
- History of craniocervical trauma;
- Be under physiotherapeutic or speech-language therapy for, respectively, craniocervical and orofacial motor dysfunction or have performed in the last three months;
- Being in use of intraoral orthodontic appliances, which produce mandibular advancement
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Obstructive sleep apnea group (G OSA)
The cervical stabilization will be performed with craniocervical flexion training aiming to strength the deep cervical flexors.
For this purpose a pressure biofeedback device (stabilizer) that allows progressive levels of pressure during exercise(22-30 mmHg) will be used, which will be increased according to the capacity of the individuals (avoiding compensations or pain).
The participant will be instructed to perform the craniocervical flexion in the supine position, the duration of the contraction will be 10 seconds followed by 10 seconds of rest (3 sets of 10 repetitions).
The sessions will be held 2 times in weeks, for 6 weeks.
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The cervical stabilization will be performed with craniocervical flexion training with two weekly sessions for 6 weeks
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无干预：Control group (GC)
The GC will be reassessed after six weeks and the same G OSA treatment will be offered after this period.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change of sleep quality
大体时间：Baseline and 7 weeks
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Sleep quality will be assessed twice through the Pittsburgh sleep quality index (PSQI), composed of nine self-administered questions, with scores scattered on a scale of zero to three.
The sum of the responses provided by the overall score, which ranges from zero to 21, where the higher the score, the worse the quality of sleep.
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Baseline and 7 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of craniocervical dysfunction index
大体时间：Baseline and 7 weeks
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The craniocervical dysfunction index evaluates the cervical function and is composed of five items: amplitude of cervical movements, presence of pain to cervical movement, presence of noises and blockages in the cervical joints, pain on the palpation of the cervical muscles and craniocervical posture.
For each evaluated item three scores are possible (0, 1 or 5) and the volunteers can be classified into four categories according to the severity of the dysfunction: no dysfunction (0 points), mild dysfunction (1 to 4 points), moderate dysfunction (5 to 9 points) and severe (10 to 25 points)
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Baseline and 7 weeks
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Change of pressure pain threshold
大体时间：Baseline and 7 weeks
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The pressure pain threshold will be evaluated by means of an analog algometer (Wagner Instruments). This appliance has a 1 cm rubber ferrule attached at its end, which will be positioned perpendicular to the muscular surface. For this, the participants will be seated in a chair, with the trunk upright, back fully supported, feet resting on the ground and hands resting on the lower limbs. The pressure pain threshold will be bilaterally assessed in the masseter (upper, middle and lower) and temporal (anterior, middle and posterior) muscles, submandibular region, posterior mandibular region, sternocleidomastoid, upper trapezius and suboccipital muscles. All points will be gradually pressed up to the intensity that the participant reports any pain intensity, this value being visualized on the equipment and recorded as pain threshold at pressure. |
Baseline and 7 weeks
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Change of presence and and severity of temporomandibular dysfunction (TMD)
大体时间：Baseline and 7 weeks
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The instrument that will be used to evaluate presence of TMD is Diagnostic criteria in research for temporomandibular disorders (RDC / TMD), which is divided in 2 axis: in Axis I allows the measurement of TMD signs and symptoms (physical evaluation) and in Axis II it evaluates the psychological and psychosocial factors (questionnaire). To measure TMD severity the Temporomandibular Index (TMI) is used, this result is obtained from RDC/TMD data from Axis I. Result is a qualification among light (0 to 0,3), moderate (0,3 a 0,6) or severe (0,6 to1) TMD according to TMI calculated. |
Baseline and 7 weeks
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Change of cervical posture
大体时间：Baseline and 7 weeks
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The posture of the head and cervical spine will be evaluated by means of digital photography, with posterior analysis in the Postural Evaluation Software (SAPo v 0.68®).
The anatomical points of the tragus, spinous process of the seventh cervical vertebra and orbicular commissure will be demarcated with Styrofoam balls in the participant's body.
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Baseline and 7 weeks
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Change of muscle strength
大体时间：Baseline and 7 weeks
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The evaluation of muscle strength of cervical flexors and extensors will be performed using a Microfet 2 manual dynamometer (Hoggan Health industries, West Jordan, USA). For the assessment of cervical flexors, the participant will be positioned in the supine position, knees extended, head and neck in neutral position. The manual dynamometer will be positioned in the midline of the frontal bone and will be held by the evaluator, while the participant performs the maximum voluntary isometric contraction of the cervical flexors. In order to evaluate the strength of the cervical extensors the participant will be positioned in the prone position, with the upper limbs next to the trunk. The manual dynamometer will be positioned in the line of the occipital protuberance. Data from three repetitions will be obtained for flexion and cervical extension, each repetition lasts 5 seconds and the rest period between the repetitions is 60 seconds. |
Baseline and 7 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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