Assessment of a New Tool to Measure Tongue Muscle Function (TOM1)
The Iowa Oral Performance Instrument (IOPI) is currently the reference tool for assessing tongue muscle function, measuring the pressure exerted by the tongue on an air-filled bulb. However, several limitations reduce its precision and clinical relevance. To overcome these, the TOngue Manometer (TOM) has been developed. This crossover study compares the two devices in healthy adults, hypothesizing that the TOM's interface will enable participants to produce higher maximal tongue pressure and endurance values, closer to their ground truth.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Pierre Cnockaert, MSc
- 電話番号：+32478136109
- メール：pierre.cnockaert@outlook.com
研究場所
-
-
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Brussels、ベルギー、1200
- 募集
- Institut de Recherche Expérimentale et Clinique (IREC) - UCLouvain; Lung, Nose, and Skin (LUNS) lab
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コンタクト：
- Pierre Cnockaert, MSc
- メール：pierre.cnockaert@outlook.com
-
主任研究者：
- Pierre Cnockaert, MSc
-
-
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:
- Being a healthy adult aged 18 to 65 years old
- Being able to understand and speak French
Exclusion Criteria:
- Being diagnosed with a cardiorespiratory or neuromuscular disease
- Being diagnosed with obstructive sleep apnea-hypopnea syndrome
- Any reason preventing the participant from completing the measurement protocol (e.g., oral pain, severe cognitive impairment, lack of cooperation, illiteracy)
- Being involved in an oropharyngeal rehabilitation program
- Having dysphagia
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：TOM session
|
New, lab-made device |
|
アクティブコンパレータ：IOPI session
|
The device currently identified as gold standard for tongue muscles assessment |
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 |
|---|---|---|
|
Tongue Pmax in elevation (pElev)
時間枠：Throughout the entire study, approximately during 14 months
|
Tongue maximal pressure (kPa) in elevation, either with the TOM or the IOPI, depending on the visit and the randomization order |
Throughout the entire study, approximately during 14 months
|
|
Tongue endurance in elevation (eElev)
時間枠：Throughout the entire study, approximately during 14 months
|
Endurance time (sec.), i.e., time during which the tongue can sustain 50% of its Pmax in elevation, measured either with the TOM or the IOPI, depending on the visit and the randomization order |
Throughout the entire study, approximately during 14 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body mass index (kg/m^2)
時間枠：Throughout the entire study, approximately during 14 months
|
Throughout the entire study, approximately during 14 months
|
|
|
Mouth, tongue, and face assessment test (through MBLF test)
時間枠：Throughout the entire study, approximately during 14 months
|
This test (MBLF test, for 'test de motricité bucco-linguo-faciale') features an assessment of several muscles (e.g., lips, tongue, and face area) that are assessed on a scale from 0 (no contraction / severe asymmetry) to 3 (normal contraction / complete symmetry). |
Throughout the entire study, approximately during 14 months
|
|
Mouth breathing questionnaire
時間枠：Throughout the entire study, approximately during 14 months
|
A score 0-3 suggests high likelihood of habitual nose breathing; 4-7 a suspicion of mouth breathing; 8 or higher a high likelihood of habitual mouth breathing |
Throughout the entire study, approximately during 14 months
|
|
Tongue thickness (POCUS)
時間枠：Throughout the entire study, approximately during 14 months
|
A submental and neck ultrasound will be performed to assess tongue muscles thickness (cm) |
Throughout the entire study, approximately during 14 months
|
協力者と研究者
捜査官
- スタディチェア：William Poncin, PhD、Université Catholique de Louvain
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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。