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

16 de junho de 2026 atualizado 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)).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Outro: 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.
Teste de diagnostico: 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.

Outro: 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).

Outro: 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).
Comportamental: 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).
Outro: 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.

Outro: 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.

Outro: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Obstructive apnea hypnopnea index
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pulse wave amplitude drop (PWAD)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Month 6
WASO (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Sleep fragmentation
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospices Civils de Lyon

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2029

Conclusão do estudo (Estimado)

1 de janeiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

20 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

18 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

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Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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