Tongue Muscular Assessment in Children With Sleep Disordered Breathing

NCT ID: NCT07273019

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-05-17

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Children referred for polysomnography for suspected OSA

Children aged 4 to 17 years old, referred to the sleep clinic for polysomnography in a context of suspected OSA

Group Type: EXPERIMENTAL

Tongue Strength Assessment

Intervention Type: OTHER

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

Polysomnography

Intervention Type: 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

Intervention Type: OTHER

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 Functioning

Intervention Type: OTHER

The following questionnaires will be filled out:

• Epworth Sleepiness Scale
• Conners

Anthropometry

Intervention Type: OTHER

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 Examination

Intervention Type: OTHER

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 Assessment

Intervention Type: OTHER

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

Interventions

Tongue Strength Assessment

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

Intervention Type: OTHER

Polysomnography

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.

Intervention Type: DIAGNOSTIC_TEST

Subjective 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

Intervention Type: OTHER

Subjective Assessment of Daytime Functioning

The following questionnaires will be filled out:

• Epworth Sleepiness Scale
• Conners

Intervention Type: OTHER

Anthropometry

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

Intervention Type: OTHER

Clinical 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

Intervention Type: OTHER

Orofacial Praxis Assessment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Bron, , France

Countries

France

Central Contacts

Patricia FRANCO, MD, PhD

Role: CONTACT

patricia.franco@chu-lyon.fr

+33 4 27 85 60 52

Aurore GUYON, PhD

Role: CONTACT

aurore.guyon@chu-lyon.fr

+33 4 27 85 52

Facility Contacts

Aurore GUYON, PhD

Role: primary

aurore.guyon@chu-lyon.fr

+33 4 27 85 52 47

Other Identifiers

2025-A01527-42

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL25_0288

Identifier Type: -

Identifier Source: org_study_id