Cervical Stabilization in Individuals With Obstructive Sleep Apnea
Cervical Stabilization in Individuals With Obstructive Sleep Apnea: a Randomized Clinical Trial
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Rio Grande Do Sul
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Santa Maria、Rio Grande Do Sul、ブラジル、97105-900
- Universidade Federal de Santa Maria
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change of sleep quality
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of craniocervical dysfunction index
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
閉塞性睡眠時無呼吸の臨床試験
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Fujian Shengdi Pharmaceutical Co., Ltd.募集
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University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症（くも膜下出血）ドイツ
Craniocervical flexion trainingの臨床試験
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University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了