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

2026年6月16日 更新者：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)).

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • フランス
      • Bron、フランス、69500
        • Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
        • コンタクト：
        • 主任研究者：
          • Patricia FRANCO, PU-PH

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：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
実験的：Infants with Down Syndrome with the CURAPROX pacifier
infants with Down Syndrome with the pacifier
デバイス：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.
他の：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.
診断テスト：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.

他の：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).

他の：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).
行動：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).
他の：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.

他の：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.

他の：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).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Obstructive apnea hypnopnea index
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Pulse wave amplitude drop (PWAD)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Month 6
WASO (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Month 6
Sleep fragmentation
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hospices Civils de Lyon

捜査官

  • 主任研究者：Patricia FRANCO, PU-PH、Hospices Civils de Lyon

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2029年1月1日

研究の完了 (推定)

2029年1月1日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年6月16日

最初の投稿 (実際)

2026年6月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月18日

QC基準を満たした最後の更新が送信されました

2026年6月16日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 69HCL26_0448
  • 2026-A01060-51 (その他の識別子：ID-RCB)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

閉塞性睡眠時無呼吸の臨床試験

CURAPROX pacifier useの臨床試験

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