Obstructive Sleep ApneaTET21NCT07658053
Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome
A study testing CURAPROX pacifier use, Pacifier diary and Polysomnography (PSG) to explore OSA in people with Obstructive Sleep Apnea and Down Syndrome (Trisomy 21), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 23 to 38 days
- Conditions the study is for
- Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
- What is being tested?
- CURAPROX pacifier use, Pacifier diary and Polysomnography (PSG) to explore OSA
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2026to 2 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 38 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Femme-Mère-Enfant, Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, 69500
Patricia FRANCO, PU-PH, 4 27 85 60 52 ext. +33, patricia.franco@chu-lyon.fr
Patricia FRANCO, PU-PH
About this study
Official title: 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.
Read more
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)).
- Being tested
- CURAPROX pacifier use, Pacifier diary, Polysomnography (PSG) to explore OSA, Non-nutritive sucking recording, Oro-myo-functional clinical evaluation
- Keywords
- Sleep apnea, Down syndrome, Oro-myo-functional development, Sleep, Non-nutritive sucking, Pacifier
- Medical subject headings
- Sleep Apnea, Obstructive, Down Syndrome, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CURAPROX pacifier useDevice
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.
Pacifier diaryOther
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.
Polysomnography (PSG) to explore OSADiagnostic test
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.
Non-nutritive sucking recordingOther
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).
Oro-myo-functional clinical evaluationOther
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).
Neurocognitive evaluationBehavioural
The Bayley Scale (4th edition) will be administered by a neuropsychologist. Global score will be calculated along with its four subscores (cognitive, language, motor).
Sleep Disturbance Scale for ChildrenOther
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.
Sleep Hygien Scale for ChildrenOther
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.
PedsQL-InfantsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Infants with Down Syndrome without CURAPROX pacifier | No intervention | Infants with Down Syndrome, included in the study OMF21 (age: 6 months), who did not use the CURAPROX pacifier |
| Infants with Down Syndrome with the CURAPROX pacifier | Experimental | infants with Down Syndrome with the pacifier Receives: Device: CURAPROX pacifier use; Other: Pacifier diary; Diagnostic Test: Polysomnography (PSG) to explore OSA; Other: Non-nutritive sucking recording; Other: Oro-myo-functional clinical evaluation; Behavioral: Neurocognitive evaluation; Other: Sleep Disturbance Scale for Children; Other: Sleep Hygien Scale for Children; Other: PedsQL-Infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive apnea hypnopnea index
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.
Measured: Month 6
Secondary outcomes (16)
Pulse wave amplitude drop (PWAD)
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.
Measured: Month 6
Hypoxic burden
Hypoxic burden (% min /h) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Measured: Month 6
Mandibular movements index
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.
Measured: Month 6
OSA severity class
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.
Measured: Month 6
Frequency of sucking bursts (/min)
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).
Measured: Month 6
Amplitude of sucking bursts (mB)
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).
Measured: Month 6
Total sleep time (TST)
TST (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Measured: Month 6
Wake after sleep onset (WASO)
WASO (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Measured: Month 6
Sleep fragmentation
Arousal index (/h) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Measured: Month 6
Sleep architecture
Percentage of sleep stages (%) will be measured during a 24h-stay at the hospital when infants are 6 months old
Measured: Month 6
Oro-facial myo-functional characteristics
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.
Measured: Month 6
Subjective parental evaluation of sleep disorders on the Sleep Disturbance Scale for Children (SDSC)
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.
Measured: Month 6
Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)
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)
Measured: Month 6
Neuropsychological evaluation
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.
Measured: Month 6
Heart rate variability (HRV)
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).
Measured: Month 6
Quality of life on the PedsQL
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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Apr 2029 (estimated)
- Study completion2 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia FRANCO, PU-PH, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658053
- Sponsor's protocol ID
- 69HCL26_0448
- Other IDs
- 2026-A01060-51
- Acronym
- TET21
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pacifier on the Development of Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT07658053
- Acronym / sponsor ID
- TET21 / 69HCL26_0448
- Keywords
- Sleep apnea, Down syndrome, Oro-myo-functional development, Sleep, Non-nutritive sucking, Pacifier
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Apr 2029 (estimated)
- Study completion
- 2 Apr 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with Down Syndrome without CURAPROX pacifier | No intervention | –Infants with Down Syndrome, included in the study OMF21 (age: 6 months), who did not use the CURAPROX pacifier |
| Infants with Down Syndrome with the CURAPROX pacifier | Experimental | Device: CURAPROX pacifier use, Other: Pacifier diary, Diagnostic Test: Polysomnography (PSG) to explore OSA, Other: Non-nutritive sucking recording, Other: Oro-myo-functional clinical evaluation, Behavioral: Neurocognitive evaluation, Other: Sleep Disturbance Scale for Children, Other: Sleep Hygien Scale for Children, Other: PedsQL-Infantsinfants with Down Syndrome with the pacifier |
Who may qualify
- Ages
- 23 to 38 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Group 1 (infants with CURAPROX pacifier)
- Group 2 (infants without CURAPROX pacifier)
Key exclusion criteria (6 listed)
- Group 1 (infants with CURAPROX pacifier)
- Group 2 (infants without CURAPROX pacifier) - Use of the CURAPROX pacifier for ≥1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CURAPROX pacifier useThe 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. | Device | Infants with Down Syndrome with the CURAPROX pacifier |
| Pacifier diaryA 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. | Other | Infants with Down Syndrome with the CURAPROX pacifier |
| Polysomnography (PSG) to explore OSAPatients 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. | Diagnostic test | Infants with Down Syndrome with the CURAPROX pacifier |
| Non-nutritive sucking recordingNon-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 | Infants with Down Syndrome with the CURAPROX pacifier |
| Oro-myo-functional clinical evaluationOrofacial 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). | Other | Infants with Down Syndrome with the CURAPROX pacifier |
| Neurocognitive evaluationThe Bayley Scale (4th edition) will be administered by a neuropsychologist. Global score will be calculated along with its four subscores (cognitive, language, motor). | Behavioural | Infants with Down Syndrome with the CURAPROX pacifier |
| Sleep Disturbance Scale for ChildrenThe 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 | Infants with Down Syndrome with the CURAPROX pacifier |
| Sleep Hygien Scale for ChildrenThe 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 | Infants with Down Syndrome with the CURAPROX pacifier |
| PedsQL-InfantsThe 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). | Other | Infants with Down Syndrome with the CURAPROX pacifier |
Primary outcome
Obstructive apnea hypnopnea index
Time frame: 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.
16 secondary outcomes
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
Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)
Time frame: Month 6
Neuropsychological evaluation
Time frame: Month 6
Heart rate variability (HRV)
Time frame: Month 6
Quality of life on the PedsQL
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia FRANCO, PU-PH principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CURAPROX pacifier use, Pacifier diary and Polysomnography (PSG) to explore OSA in people with Obstructive Sleep Apnea and Down Syndrome (Trisomy 21), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia FRANCO, PU-PH (4 27 85 60 52 ext. +33, patricia.franco@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive apnea hypnopnea index (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.