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

2026년 6월 16일 업데이트: 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)).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Bron, 프랑스, 69500
        • Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
        • 연락하다:
        • 수석 연구원:
          • Patricia FRANCO, PU-PH

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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
실험적: Infants with Down Syndrome with the CURAPROX pacifier
infants with Down Syndrome with the pacifier
장치: 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.
다른: 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.
진단 검사: 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.

다른: 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).

다른: 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).
행동: 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).
다른: 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.

다른: 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.

다른: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Obstructive apnea hypnopnea index
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pulse wave amplitude drop (PWAD)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: Month 6
WASO (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Sleep fragmentation
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospices Civils de Lyon

수사관

  • 수석 연구원: Patricia FRANCO, PU-PH, Hospices Civils de Lyon

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2029년 1월 1일

연구 완료 (추정된)

2029년 1월 1일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 6월 16일

처음 게시됨 (실제)

2026년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 16일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 69HCL26_0448
  • 2026-A01060-51 (기타 식별자: ID-RCB)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐쇄성 수면 무호흡증에 대한 임상 시험

CURAPROX pacifier use에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Equatorial Guinea

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다