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

Sponsor
Hospices Civils de Lyon
Study ID
NCT07195253
Status
Recruiting
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Conditions

  • Down Syndrome (Trisomy 21)
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
5 Months - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • 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
    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
    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
    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
    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
    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.

Study Details

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.

Key Dates

First listed
Sep 26, 2025
Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Infants with Down Syndrome
    6 month-old infants with Down Syndrome recorded by polysomnography

Primary Outcome Measure

Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI) [ Time Frame: Day 1 ]

Central Contacts

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