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Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome (TET21)

16 de junio de 2026 actualizado por: Hospices Civils de Lyon

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

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)).

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Francia
      • Bron, Francia, 69500
        • Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
        • Contacto:
        • Investigador principal:
          • Patricia FRANCO, PU-PH

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Infants with Down Syndrome without CURAPROX pacifier
Infants with Down Syndrome, included in the study OMF21 (age: 6 months), who did not use the CURAPROX pacifier
Experimental: Infants with Down Syndrome with the CURAPROX pacifier
infants with Down Syndrome with the pacifier
Dispositivo: 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.
Otro: 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.
Prueba de diagnóstico: 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.

Otro: 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).

Otro: 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).
Conductual: 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).
Otro: 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.

Otro: 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.

Otro: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Obstructive apnea hypnopnea index
Periodo de tiempo: Month 6
OAHI (/h) will be measured by PSG. Night PSG will take place during a 24h-stay at the hospital when infants are 6 months old.
Month 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pulse wave amplitude drop (PWAD)
Periodo de tiempo: Month 6
PWAD (/h) will be measured by PSG. Night PSG will take place during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Hypoxic burden
Periodo de tiempo: Month 6
Hypoxic burden (% min /h) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Mandibular movements index
Periodo de tiempo: Month 6
Mandibular movements index (/h) will be measured using the JAWAC system during the PSG of a 24h-stay at the hospital when infants are 6 months old.
Month 6
OSA severity class
Periodo de tiempo: Month 6

Determined based on the value of OAHI on PSG at 6 months:

  • No OSA : IAHO <1,5/h
  • Light OSA : IAHO ≥1,5/h
  • Moderate OSA : IAHO [5 ;10/h[
  • Severe OSA : IAHO ≥10/

Night PSG will be recorded during the 24h-hospital stay at 6 month old.
Month 6
Frequency of sucking bursts (/min)
Periodo de tiempo: Month 6
Sucking performance will be measured by non-nutritive sucking recording. Non-nutritive sucking recording will take place at 1 month (during a consultation in the department of genetics) and at 6 months (during the 24h-stay at the hospital for polysomnography).
Month 6
Amplitude of sucking bursts (mB)
Periodo de tiempo: Month 6
Sucking performance will be measured by non-nutritive sucking recording. Non-nutritive sucking recording will take place at 1 month (during a consultation in the department of genetics) and at 6 months (during the 24h-stay at the hospital for polysomnography).
Month 6
Total sleep time (TST)
Periodo de tiempo: Month 6
TST (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Wake after sleep onset (WASO)
Periodo de tiempo: Month 6
WASO (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Sleep fragmentation
Periodo de tiempo: Month 6
Arousal index (/h) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Sleep architecture
Periodo de tiempo: Month 6
Percentage of sleep stages (%) will be measured during a 24h-stay at the hospital when infants are 6 months old
Month 6
Oro-facial myo-functional characteristics
Periodo de tiempo: Month 6

12 subscores and total score on the OMES-E (Orofacial Myofunctional Evaluation with Scores - Expanded protocol ; score) Clinical examination of oro-facial myo-functional characteristics will take place during the 24h-stay at the hospital for polysomnography (age: 6 months).

Total score ranges from 0 to 100. Higher score means better outcome.
Month 6
Subjective parental evaluation of sleep disorders on the Sleep Disturbance Scale for Children (SDSC)
Periodo de tiempo: Month 6

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

Total score ranges from 22 to 110. Higher scores mean worse outcomes.
Month 6
Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)
Periodo de tiempo: Month 6

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

Positive scores are worse than negative scores. SHSC will be filled-in by parents during the hospital-stay of their child for polysomnography (age: 6 months)
Month 6
Neuropsychological evaluation
Periodo de tiempo: Month 6

Neurosychological evaluation will be conducted by an experienced neuropsychologist using the Bayley Scales of Infant and Toddler Development (4th edition). Total score and subscores (posture, hand-eye coordination, language, sociability) will be collected. Neurosychological evaluation will be conducted on the morning following polysomnography, during the 24h-hospital stay of the child (age: 6 months).

Scores range from 0 to 160. Higher scores mean better outcomes.
Month 6
Heart rate variability (HRV)
Periodo de tiempo: Month 6

Time-domain HRV indices: RR, HR, NN50, pNN50, SDNN, RMSSD Frequency-domain HRV indices: Ptot, VLF, LF, HF, LFnu, HFnu, LF/HF ratio. HRV measures will be compared between the sample of children with DS and a control group of healthy children from the AuBE cohort (cohort from a previous study).

HRV indices will be calculated for the electrocardiogram signal recorded during the PSG (age: 6 months).
Month 6
Quality of life on the PedsQL
Periodo de tiempo: Month 6

Results of the PedsQL consist in 1 total score + 5 subscores (physical functioning, physical symptoms, emotional functioning, social functioning, cognitive functioning).

The PedsQL questionnaire will be filled-in by parents during the hospital-stay of their child for polysomnography (age: 6 months).

Total score ranges from 0 to 144. Higher score means worse outcomes.
Month 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospices Civils de Lyon

Investigadores

  • Investigador principal: Patricia FRANCO, PU-PH, Hospices Civils de Lyon

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de enero de 2029

Finalización del estudio (Estimado)

1 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 69HCL26_0448
  • 2026-A01060-51 (Otro identificador: ID-RCB)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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