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Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome

ConditionsObstructive Sleep ApneaDown Syndrome (Trisomy 21)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-6
SponsorHospices Civils de Lyon

About this trial

Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system.

Down Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study by Fauroux et al. (2024), OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting the need to develop new strategies to prevent and to screen OSA early in infancy.

OSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly.

The primary objective of the present study is to explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS.

The main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance.

Data from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 6 months (±3 weeks)

Diagnosed with Trisomy 21

Affiliated to a social security scheme

With informed consent of the 2 legal representatives

Disqualifiers

Diagnosed with mosaic Down syndrome

Born preterm (gestation age at birth <37 weeks)

Treated for OSA with Continuous Positive Airway Pressure

Known allergy to silicone

Trial population

This study involves 6-month-old infants diagnosed with Down syndrome.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Polysomnography (PSG) to explore OSA

    Diagnostic test

    Patients will undergo full-night PSG (including electrocardiogram to monitor heart rate and the JAWAC system to record mandibular movements) in the sleep unit of Hôpital Femme-Mère-Enfant (Bron, France) to explore OSA, included in the routine care of children with DS. OSA diagnosis will be made based on the obstructive apnea-hypopnea index (OAHI) resulting from the PSG. OSA will be diagnosed when OAHI ≥1.5/hour.

  • Oro-myo-functional clinical evaluation

    Other intervention

    Orofacial myofunctional evaluation will be conducted by a physiotherapist according to the OMES-E (Orofacial Myofunctional Evaluation with Scores for Nursing Infants).

  • Sleep Disturbance Scale for Children

    Other intervention

    The Sleep Disturbance Scale for Children is a short questionnaire answered by parents about their child's sleep disorders. Total score and scores for each sleep disorder will be calculated, according to the classical procedures during hospitalization of all children in our sleep unit.

  • Non-nutritive sucking recording

    Other intervention

    Non-nutritive sucking performance will be recorded through an experimental method using a classical pacifier, equipped with pressure sensors. Recording will last about 10 minutes. Variables related to sucking performance (maximum amplitude, frequency of sucking bursts, etc.) will be recorded.

  • Neurocognitive evaluation

    Behavioral

    The Bayley Scales of Infant and Toddler Development (4th edition) will be administered by a neuropsychologist. Five subset scores (cognitive, receptive communication, expressive communication, fine motor, gross motor) will be calculated, along with three composite scores (cognitive, language, motor).

  • PedsQL-Infants

    Other intervention

    The PedsQL-Infants questionnaire is designed to evaluate quality of life in infants. It will be given to parents during their child's hospitalization.

  • Sleep Hygiene Scale for Children

    Other intervention

    The Sleep Hygiene Scale for Children is a short questionnaire answered by parents about behavioral sleep disorders. Total result ("sleep hygiene issue" : yes/no) and three scores (attachment parenting, translational coping, screen exposure) will be calculated, according to the classical procedures during hospitalization of all young children in our sleep unit.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Infants with Down Syndrome7 interventions

Trial outcomes

Primary outcomes

1

Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI)

Number of peaks during sucking bursts will be measured by non-nutritive sucking recording. OAHI will be measured by PSG.

Time frame
Day 1

Secondary outcomes

1

Oro-facial myo-functional characteristics

Variables obtained from electrophysiological (non-nutritive sucking recording) and clinical (OMES-E: 1 total score + 12 subscores) examination of oro-facial myo-functional characteristics.

Time frame
D1
2

Respiratory PSG indices

Obstructive apnea-hypopnea index (OAHI), apnea-hypopnea index (AHI), respiratory effort-related arousal index (RERA), mean CO2, time spent with CO2 \>50mmHg, mean SpO2, desaturation index \>3%, pulse wave amplitude drop (PWAD), hypoxic burden. PSG sleep architecture parameters: total sleep time (TST), sleep efficiency (TST / time in bed), sleep onset latency (SOL), wake after sleep onset (WASO), percentage of sleep stages (N1, N2, N3, REM), arousal index, awakening index, mandibular movement index.

Time frame
Night between Day 1 and Day 2.
3

Subjective parental evaluation of sleep disorders on the Sleep Disturbance Scale for Children (SDSC)

SDSC: 1 total score and subscores (insomnia, sleep disordered breathing, non-restorative sleep)

Time frame
Day 1
4

Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)

1 total result ("sleep hygiene issue" : yes/no) and three scores (attachment parenting, translational coping, screen exposure)

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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