Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome

Official title

Effects of a Pacifier on the Development of Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome

Overview

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, 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. Therefore, there is a need to develop new strategies to prevent 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 evaluate the effects of a pacifier used by infants with Down Syndrome (from the age of 1 months) on the severity of OSA at the age of 6 months, by comparing a group of infants with the pacifier vs a group of infants without the pacifier. The main hypothesis is that infants who used the pacifier from 1 month- to 6 month-old will have lower OSA severity (estimated by the obstructive apnea hypopnea index on polysomnography (PSG)).

Interventions

• Device CURAPROX pacifier use
  The CURAPROX pacifier is a biofunctional pacifier developed to promote nasal breathing and a healthy oro-facial development, available for sale to the general public. It will be given to infants when they are 1 month old, until the last visit at 6 months.
• Other Pacifier diary
  A diary will be filled in by the caregivers for 2 consecutive days each month until the visit at the hospital (at 6 months). Parents will be reminded to fill in the dairy by a phone call.
• Diagnostic test Polysomnography (PSG) to explore OSA
  Patients will undergo full-night PSG (including electrocardiogram to monitor heart rate and the JAWAC system to record mandibular movements) at the age of 6 months 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.
• Other Non-nutritive sucking recording
  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. It will be recorded on the day of inclusion (1 month old) and on the day of polysomnography (6 months old).
• Other Oro-myo-functional clinical evaluation
  Orofacial myofunctional evaluation will be conducted by a physiotherapist according to the OMES-E (Orofacial Myofunctional Evaluation with Scores for Nursing Infants) during the hospitalization for polysomnography (at 6 months old).
• Behavioral Neurocognitive evaluation
  The Bayley Scale (4th edition) will be administered by a neuropsychologist. Global score will be calculated along with its four subscores (cognitive, language, motor).
• Other Sleep Disturbance Scale for Children
  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 for polysomnography in the sleep unit.
• Other Sleep Hygien Scale for Children
  The Sleep Hygiene Scale for Children is a short questionnaire answered by parents about their child's sleep habits. Total score and scores for each sleep disorder will be calculated, according to the classical procedures during hospitalization for polysomnography in the sleep unit.
• Other PedsQL-Infants
  The PedsQL-Infants questionnaire is designed to evaluate quality of life in infants. It will be given to parents during their child's hospitalization for polysomnography (at 6 months old).

Primary outcome measures

• Obstructive apnea hypnopnea index [Time frame: Month 6]

Secondary outcome measures (12)

• Pulse wave amplitude drop (PWAD) [Time frame: Month 6]
• Hypoxic burden [Time frame: Month 6]
• Mandibular movements index [Time frame: Month 6]
• OSA severity class [Time frame: Month 6]
• Frequency of sucking bursts (/min) [Time frame: Month 6]
• Amplitude of sucking bursts (mB) [Time frame: Month 6]
• Total sleep time (TST) [Time frame: Month 6]
• Wake after sleep onset (WASO) [Time frame: Month 6]
• Sleep fragmentation [Time frame: Month 6]
• Sleep architecture [Time frame: Month 6]
• Oro-facial myo-functional characteristics [Time frame: Month 6]
• Subjective parental evaluation of sleep disorders on the Sleep Disturbance Scale for Children (SDSC) [Time frame: Month 6]

Eligibility criteria

Inclusion criteria

• Group 1 (infants with CURAPROX pacifier)

• Age 1 month (±1 week)
• Children diagnosed with free and homogeneous trisomy 21
• For whom a consultation is planned at \~1 month in the department of genetics
• Affiliated to a social security scheme
• With informed consent of the 2 legal representatives
• Group 2 (infants without CURAPROX pacifier)

• Infants included in the OMF21 study (sponsored by HCL, n°ID-RCB 2025-A01900-49, approved by ethical committee Nord-Ouest IV on October 9th 2025)
• With informed consent of the 2 legal representatives for re-use of the data

Exclusion criteria

• Group 1 (infants with CURAPROX pacifier)

• Diagnosed with mosaic trisomy 21
• Born preterm (gestation age at birth <37 weeks)
• Known allergy to silicone
• Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
• Group 2 (infants without CURAPROX pacifier) - Use of the CURAPROX pacifier for ≥1 month

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 1 center

• Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de — Bron

Identifiers

NCT: NCT07658053 · 69HCL26_0448 · 2026-A01060-51

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗