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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01527-42 | Other Identifier | ID-RCB |
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Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.
The primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children referred for polysomnography for suspected OSA | Experimental | Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tongue Strength Assessment | Other | The following items will be assessed:
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| Measure | Description | Time Frame |
|---|---|---|
| Tongue peak pressure during protrusion | Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Tongue peak pressure during elevation and swallowing | Tongue peak pressure during elevation and swallowing movements will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome. | Day 1 |
| Tongue mobility restriction |
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Inclusion Criteria:
Exclusion Criteria:
Insufficient comprehension of French language
Regarding patients with suspected OSA type I or II:
Regarding patients with suspected OSA type III:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia FRANCO, MD, PhD | Contact | +33 4 27 85 60 52 | patricia.franco@chu-lyon.fr | |
| Aurore GUYON, PhD | Contact | +33 4 27 85 52 | aurore.guyon@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant | Recruiting | Bron | 69500 | France |
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Children (4-17 years old) referred to the sleep clinic for polysomnography in a context of suspected obstructive sleep apnea.
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|
| Polysomnography | Diagnostic Test | Patients will undergo full-night polysomnography (including the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA. |
|
| Subjective Assessment of Sleep-Disordered Breathing | Other | The following questionnaires will be filled out:
|
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| Subjective Assessment of Daytime Functioning | Other | The following questionnaires will be filled out:
|
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| Anthropometry | Other | The following measures will be collected via the Quick Tongue-Tie Assessment tool:
|
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| Clinical Examination | Other | The following variables will be collected during a clinical examination:
|
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| Orofacial Praxis Assessment | Other | Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF). |
|
Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured using the Quick Tongue-Tie Assessment tool. Higher values are considered a better outcome. |
| Day 1 |
| Orofacial praxis | Orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test, which ranges from 0 to 111. Higher scores indicate a better outcome. | Day 1 |
| Obstructive apnea-hypopnea index (OAHI) | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. | Day 1 |
| Central apnea-hypopnea index | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. | Day 1 |
| Mixed apnea-hypopnea index | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. | Day 1 |
| Respiratory effort index | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. | Day 1 |
| Respiratory effort-related arousal index (RERA) | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. | Day 1 |
| Mean CO2 | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Max CO2 | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Time spent with CO2 > 50mmHg | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Mean SpO2 | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Desaturation index ≥ 3% | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Desaturation index ≥ 4% | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Time spent with SaO2 < 90% | Respiratory parameters will be assessed by night polysomnography. | Day 1 |
| Total sleep time | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Sleep onset latency | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Wake after sleep onset | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Duration of sleep N1 | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Duration of sleep N2 | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Duration of sleep N3 | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Duration of REM sleep | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Sleep efficiency | Sleep architecture parameters will be assessed by night polysomnography. | Day 1 |
| Score on Abreu's Questionnaire | Total score ranges from 0 to 16. Higher scores indicate a worse outcome. | Day 1 |
| Score on the OSA-18 Questionnaire | This questionnaire assesses quality of life associated with sleep-disordered breathing in children. Total score ranges from 18 to 126. Higher scores indicate a worse outcome. | Day 1 |
| Score on the Pediatric Sleep Questionnaire | This questionnaire assesses symptoms and repercussions of sleep-disordered breathing in children. Total score ranges from 0 to 22. Higher scores indicate a worse outcome. | Day 1 |
| Score on the Spruyt & Gozal Questionnaire | This questionnaire assesses sleep-disordered breathing in children. Total score ranges from 0 to 4. Higher scores indicate a worse outcome. | Day 1 |
| Score on the Sleep Disturbance Scale for Children | This questionnaire assesses sleep disturbance in children. Total score ranges from 25 to 125. Higher scores indicate a worse outcome. | Day 1 |
| Score on the French Version of the Sleepiness Scale for Adolescents | This questionnaire assesses excessive daytime sleepiness. Total score ranges from 25 to 125. Higher scores indicate a worse outcome. | Day 1 |
| Score on the Conners Rating Scale | This questionnaire assesses hyperactivity. Total score ranges from 0 to 30. Higher scores indicate a worse outcome. | Day 1 |
| Medical history | Medical history is conducted by a doctor. It will be used to determine the type of OSA (craniofacial and/or syndromic comorbidities classify OSA as type III; otherwise, OSA is type II in the presence of obesity, or type I in the absence of obesity). | Day 1 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| D000886 | Anthropometry |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D010808 | Physical Examination |
| D008919 | Investigative Techniques |
| D001699 | Biometry |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
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