Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.
Our team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.
Primary objective: To describe tongue structure and function in children with oSDB.
Secondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：William Poncin, Professor
- 電話番号：0471 90 66 23
- メール：william.poncin@uclouvain.be
研究場所
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Liège、ベルギー、4000
- 募集
- CHC MontLégia hospital
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コンタクト：
- Matthieu Thimmesch, MD
- 電話番号：0032 4 355 50 20
- メール：Matthieu.THIMMESCH@chc.be
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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
サンプリング方法
調査対象母集団
Children with obstructive sleep-disordered breathing, with a scheduled polysomnography or who received a polysomnography within the past 6 months, and without any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
説明
Inclusion Criteria:
- Aged 4 to 17 years
- Scheduled polysomnography, or polysomnography performed within the past 6 months
- Positive Pediatric Sleep Questionnaire (8 "yes" answers or more)
Exclusion Criteria:
- Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III
- Any condition that could interfere with the assessments
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
- 観測モデル：CASE_CONTROL
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Unique arm, cross-sectional assessment
Single assessment visit |
This cross-sectional assessment includes outcomes related to tongue structure, tongue function, and questionnaires |
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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Tongue strength assessment
時間枠：At enrollment, during the single study visit (Day 1)
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Maximal pressure exerted by the tongue against an air-filled bulb (in kPa) in protrusion, elevation, and during swallowing. |
At enrollment, during the single study visit (Day 1)
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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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Tongue morphology assessment
時間枠：At enrollment, during the single study visit (Day 1)
|
Submental ultrasound in frontal and sagittal plane, to assess the thickness of tongue muscles (cm) |
At enrollment, during the single study visit (Day 1)
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Tongue frenulum assessment
時間枠：At enrollment, during the single study visit (Day 1)
|
Tongue range of motion ratio, reflecting the restriction imposed by the lingual frenulum. It is computed as the maximal mouth opening with the tongue tip held at the incisive papilla (mm) divided by the maximal mouth opening (mm). |
At enrollment, during the single study visit (Day 1)
|
|
Tongue mobility score
時間枠：At enrollment, during the single study visit (Day 1)
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Motricité Bucco-Linguo-Faciale (MBLF) test, where several movements are scored between 0 and 3 regarding muscular contraction or symmetry. |
At enrollment, during the single study visit (Day 1)
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Obstructive apnea-hypopnea index
時間枠：At enrollment, during the single study visit (Day 1)
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Number of obstructive apneas and hypopneas per hour of sleep (events/hour) assessed through polysomnography |
At enrollment, during the single study visit (Day 1)
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Breathing pattern questionnaire
時間枠：At enrollment, during the single study visit (Day 1)
|
Mouth breathing questionnaire from Abreu et al., considered positive if two major items, or one major and two minor items, are answered "yes" |
At enrollment, during the single study visit (Day 1)
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Quality of life questionnaire
時間枠：At enrollment, during the single study visit (Day 1)
|
PedsQL questionnaire (Pediatric Quality of Life Inventory), divided into parent report and child self-report questionnaires, with several items scored from 0 to 4. Higher scores indicate more problems related to the quality of life. |
At enrollment, during the single study visit (Day 1)
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Sleep quality questionnaire
時間枠：At enrollment, during the single study visit (Day 1)
|
The Pediatric Sleep Questionnaire will be administered to parents. Items are answered "yes", "no", or "I don't know", and higher scores indicate more signs of obstructive sleep-disordered breathing. |
At enrollment, during the single study visit (Day 1)
|
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Sleep-related quality of life questionnaire
時間枠：At enrollment, during the single study visit (Day 1)
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The Obstructive Sleep Apnea-18 (OSA-18) questionnaire will be administered to parents. Higher scores indicate a greater impact of sleep-disordered breathing on quality of life. |
At enrollment, during the single study visit (Day 1)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
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