Tongue Muscular Assessment in Children With Sleep Disordered Breathing

N/ANot Yet RecruitingNCT07273019

Hospices Civils de Lyon78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Tongue Strength AssessmentOTHER

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

PolysomnographyDIAGNOSTIC_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 BreathingOTHER

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

Subjective Assessment of Daytime FunctioningOTHER

The following questionnaires will be filled out: * Epworth Sleepiness Scale * Conners

AnthropometryOTHER

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

Clinical ExaminationOTHER

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

Orofacial Praxis AssessmentOTHER

Bucco-Linguo-Facial Motor Skills will be assessed through the test "Motricité Bucco-Linguo-Faciale" (MBLF).

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Femme-Mère-Enfant : Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant

Bron, France

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

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.

Time frame: Day 1

Tongue mobility restriction

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.

Time frame: 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.

Time frame: Day 1

Obstructive apnea-hypopnea index (OAHI)

Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

Time frame: Day 1

Central apnea-hypopnea index

Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

Time frame: Day 1

Mixed apnea-hypopnea index

Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

Time frame: Day 1

Respiratory effort index

Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

Time frame: Day 1

Respiratory effort-related arousal index (RERA)

Respiratory parameters will be assessed by night polysomnography. A higher index indicates a worse outcome.

Time frame: Day 1

Mean CO2

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Max CO2

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Time spent with CO2 > 50mmHg

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Mean SpO2

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Desaturation index ≥ 3%

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Desaturation index ≥ 4%

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Time spent with SaO2 < 90%

Respiratory parameters will be assessed by night polysomnography.

Time frame: Day 1

Total sleep time