An interventional study of CURAPROX pacifier use and Pacifier diary in Obstructive Sleep Apnea and Down Syndrome (Trisomy 21), sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 23 Days to 38 Days. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention
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)).
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Group 1 (infants with CURAPROX pacifier)
Group 2 (infants without CURAPROX pacifier)
Exclusion Criteria:
Group 1 (infants with CURAPROX pacifier)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 pacifier
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
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.
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.
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 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).
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).
The Bayley Scale (4th edition) will be administered by a neuropsychologist. Global score will be calculated along with its four subscores (cognitive, language, motor).
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.
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.
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).
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.
Time frame: Month 6
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.
Time frame: Month 6
Hypoxic burden
Hypoxic burden (% min /h) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Month 6
Total sleep time (TST)
TST (min) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Time frame: 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.
Time frame: Month 6
Sleep fragmentation
Arousal index (/h) will be measured during a 24h-stay at the hospital when infants are 6 months old.
Time frame: Month 6
Sleep architecture
Percentage of sleep stages (%) will be measured during a 24h-stay at the hospital when infants are 6 months old
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Month 6
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2029, 29 months later.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 29 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: start Jul 2026 → Nov 2026, primary completion Jan 2029 → Apr 2029 and completion Jan 2029 → Apr 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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