Obstructive Sleep Apnea
Conditions
Keywords
Tongue, Motor functions, Sleep, Sleep apnea
Brief summary
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.
Interventions
The following items will be assessed: 1. Tongue peak pressure during 3 seconds of tongue protrusion 2. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 seconds of tongue elevation 3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing
DIAGNOSTIC_TESTPolysomnography
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.
OTHERSubjective Assessment of Sleep-Disordered Breathing
The following questionnaires will be filled out: * OSA-18 * Pediatric Sleep Questionnaire (PSQ) * Spruyt \& Gozal * Sleep Disturbance Scale for Children * Abreu et al.'s questionnaire
OTHERSubjective Assessment of Daytime Functioning
The following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners
OTHERAnthropometry
The following measures will be collected via the Quick Tongue-Tie Assessment tool: 1. Maximal mouth opening 2. Maximal mouth opening with tongue to palate
OTHERClinical Examination
The following variables will be collected during a clinical examination: 1. Age 2. Sex 3. Weight 4. Height 5. BMI 6. Friedman score 7. Mallampati score 8. Medical history
Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Children (4-17 years old) referred to the sleep clinic for polysomnography in a context of suspected obstructive sleep apnea.
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* With suspected sleep-disordered breathing * Referred for polysomnography * Affiliated to a social security scheme * With informed consent from both legal representatives
Exclusion criteria
* Insufficient comprehension of French language * Regarding patients with suspected OSA type I or II: * Neurological, cardiac, or respiratory conditions other than sleep disorders and their repercussions * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition) * Previous surgery performed on the upper airway or the oral cavity * Malformation of the skull, the upper airway or the oral cavity * Regarding patients with suspected OSA type III: * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition) * Intellectual deficit impeding the understanding of instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tongue peak pressure during protrusion | Day 1 | Tongue peak pressure during protrusion will be measured using the IOPI (Iowa Oral Performance Instrument) device. Higher tongue pressure is considered a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tongue peak pressure during elevation and swallowing | Day 1 | 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. |
| Tongue mobility restriction | Day 1 | 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. |
| Orofacial praxis | Day 1 | 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. |
| Obstructive apnea-hypopnea index (OAHI) | Day 1 | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. |
| Central apnea-hypopnea index | Day 1 | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. |
| Mixed apnea-hypopnea index | Day 1 | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. |
| Respiratory effort index | Day 1 | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. |
| Respiratory effort-related arousal index (RERA) | Day 1 | Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome. |
| Mean CO2 | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Max CO2 | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Time spent with CO2 > 50mmHg | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Mean SpO2 | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Desaturation index ≥ 3% | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Desaturation index ≥ 4% | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Time spent with SaO2 < 90% | Day 1 | Respiratory parameters will be assessed by night polysomnography. |
| Total sleep time | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Sleep onset latency | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Wake after sleep onset | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Duration of sleep N1 | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Duration of sleep N2 | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Duration of sleep N3 | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Duration of REM sleep | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Sleep efficiency | Day 1 | Sleep architecture parameters will be assessed by night polysomnography. |
| Score on Abreu's Questionnaire | Day 1 | Total score ranges from 0 to 16. Higher scores indicate a worse outcome. |
| Score on the OSA-18 Questionnaire | Day 1 | 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. |
| Score on the Pediatric Sleep Questionnaire | Day 1 | 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. |
| Score on the Spruyt & Gozal Questionnaire | Day 1 | This questionnaire assesses sleep-disordered breathing in children. Total score ranges from 0 to 4. Higher scores indicate a worse outcome. |
| Score on the Sleep Disturbance Scale for Children | Day 1 | This questionnaire assesses sleep disturbance in children. Total score ranges from 25 to 125. Higher scores indicate a worse outcome. |
| Score on the French Version of the Sleepiness Scale for Adolescents | Day 1 | This questionnaire assesses excessive daytime sleepiness. Total score ranges from 25 to 125. Higher scores indicate a worse outcome. |
| Score on the Conners Rating Scale | Day 1 | This questionnaire assesses hyperactivity. Total score ranges from 0 to 30. Higher scores indicate a worse outcome. |
| Medical history | Day 1 | 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). |
Countries
France
Contacts
CONTACTPatricia FRANCO, MD, PhD
CONTACTAurore GUYON, PhD
Outcome results
None listed