Obstructive Sleep ApneaOMF21NCT07195253
Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
An observational study of 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 5 to 6 months
- Conditions the study is for
- Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
- What is being tested?
- Polysomnography (PSG) to explore OSA, Oro-myo-functional clinical evaluation and Sleep Disturbance Scale for Children
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Observational
- 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 5 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: This study involves 6-month-old infants diagnosed with Down syndrome.
Who may be able to join
- (infants with Down Syndrome)
- Aged 6 months (±3 weeks)
- Diagnosed with Trisomy 21
- Affiliated to a social security scheme
- With informed consent of the 2 legal representatives
Who cannot join
- Diagnosed with mosaic Down syndrome
- Born preterm (gestation age at birth <37 weeks)
- Treated for OSA with Continuous Positive Airway Pressure
- Known allergy to silicone
- Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
- Refusal from legal representatives.
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, 1 recruiting
- Recruiting
Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, 69500
Patricia PF FRANCO, MD/PHD, +33 4 27 85 60 52, patricia.franco@chu-lyon.fr
About this study
Official title: Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea 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 by Fauroux et al. (2024), 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. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting the need to develop new strategies to prevent and to screen 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 explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS.
The main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance.
Data from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.
- Being tested
- Polysomnography (PSG) to explore OSA, Oro-myo-functional clinical evaluation, Sleep Disturbance Scale for Children, Non-nutritive sucking recording, Neurocognitive evaluation
- Keywords
- sleep apnea, Down Syndrome, oro-myofunctional development, sleep, non-nutritive sucking
- 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.
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) 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.
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).
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 of all children in our sleep unit.
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.
Neurocognitive evaluationBehavioural
The Bayley Scales of Infant and Toddler Development (4th edition) will be administered by a neuropsychologist. Five subset scores (cognitive, receptive communication, expressive communication, fine motor, gross motor) will be calculated, along with three composite scores (cognitive, language, motor).
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.
Sleep Hygiene Scale for ChildrenOther
The Sleep Hygiene Scale for Children is a short questionnaire answered by parents about behavioral sleep disorders.
Total result ("sleep hygiene issue" : yes/no) and three scores (attachment parenting, translational coping, screen exposure) will be calculated, according to the classical procedures during hospitalization of all young children in our sleep unit.
| Study group | Role | What they receive |
|---|---|---|
| Infants with Down Syndrome | 6 month-old infants with Down Syndrome recorded by polysomnography Receives: Diagnostic Test: Polysomnography (PSG) to explore OSA; Other: Oro-myo-functional clinical evaluation; Other: Sleep Disturbance Scale for Children; Other: Non-nutritive sucking recording; Behavioral: Neurocognitive evaluation; Other: PedsQL-Infants; Other: Sleep Hygiene Scale for Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI)
Number of peaks during sucking bursts will be measured by non-nutritive sucking recording.
OAHI will be measured by PSG.
Measured: Day 1
Secondary outcomes (10)
Oro-facial myo-functional characteristics
Variables obtained from electrophysiological (non-nutritive sucking recording) and clinical (OMES-E: 1 total score + 12 subscores) examination of oro-facial myo-functional characteristics.
Measured: D1
Respiratory PSG indices
Obstructive apnea-hypopnea index (OAHI), apnea-hypopnea index (AHI), respiratory effort-related arousal index (RERA), mean CO2, time spent with CO2 >50mmHg, mean SpO2, desaturation index >3%, pulse wave amplitude drop (PWAD), hypoxic burden.
PSG sleep architecture parameters: total sleep time (TST), sleep efficiency (TST / time in bed), sleep onset latency (SOL), wake after sleep onset (WASO), percentage of sleep stages (N1, N2, N3, REM), arousal index, awakening index, mandibular movement index.
Measured: Night between Day 1 and Day 2.
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)
Measured: Day 1
Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)
1 total result ("sleep hygiene issue" : yes/no) and three scores (attachment parenting, translational coping, screen exposure)
Measured: Day 1
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.
Measured: Night between Day 1 and Day 2.
Electrophysiological evaluation of sucking
All other variables obtained from non-nutritive sucking recording
Measured: Day 1
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.
Measured: Day 2
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)
Measured: Day 1
Clinical examination of oro-facial myo-functional characteristics
Variables obtained from clinical examination of oro-facial myo-functional characteristics driven by an experienced physiotherapist following the Expanded protocole of Orofacial Myofunctional Evaluation with Scores (OMES-E).
Measured: Day 2
PSG sleep architecture parameters
Total sleep time (TST), sleep efficiency (TST / time in bed), sleep onset latency (SOL), wake after sleep onset (WASO), percentage of sleep stages (N1, N2, N3, REM), arousal index, awakening index, mandibular movement index
Measured: Night between Day 1 and Day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195253
- Sponsor's protocol ID
- 69HCL25_0309
- Other IDs
- 2025-A01900-49
- Acronym
- OMF21
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT07195253
- Acronym / sponsor ID
- OMF21 / 69HCL25_0309
- Keywords
- sleep apnea, Down Syndrome, oro-myofunctional development, sleep, non-nutritive sucking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 26 Sep 2025 (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 by Fauroux et al. (2024), 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. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting the need to develop new strategies to prevent and to screen 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 explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS.
The main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance.
Data from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with Down Syndrome | – | Diagnostic Test: Polysomnography (PSG) to explore OSA, Other: Oro-myo-functional clinical evaluation, Other: Sleep Disturbance Scale for Children, Other: Non-nutritive sucking recording, Behavioral: Neurocognitive evaluation, Other: PedsQL-Infants, Other: Sleep Hygiene Scale for Children6 month-old infants with Down Syndrome recorded by polysomnography |
Who may qualify
- Ages
- 5 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study involves 6-month-old infants diagnosed with Down syndrome.
Key inclusion criteria (5 listed)
- (infants with Down Syndrome)
- Aged 6 months (±3 weeks)
- Diagnosed with Trisomy 21
- Affiliated to a social security scheme
- With informed consent of the 2 legal representatives
Key exclusion criteria (6 listed)
- Diagnosed with mosaic Down syndrome
- Born preterm (gestation age at birth <37 weeks)
- Treated for OSA with Continuous Positive Airway Pressure
- Known allergy to silicone
- Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
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 |
|---|---|---|
| Polysomnography (PSG) to explore OSAPatients will undergo full-night PSG (including electrocardiogram to monitor heart rate and the JAWAC system to record mandibular movements) 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 |
| 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). | Other | Infants with Down Syndrome |
| 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 of all children in our sleep unit. | Other | Infants with Down Syndrome |
| 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. | Other | Infants with Down Syndrome |
| Neurocognitive evaluationThe Bayley Scales of Infant and Toddler Development (4th edition) will be administered by a neuropsychologist. Five subset scores (cognitive, receptive communication, expressive communication, fine motor, gross motor) will be calculated, along with three composite scores (cognitive, language, motor). | Behavioural | Infants with Down Syndrome |
| 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. | Other | Infants with Down Syndrome |
| Sleep Hygiene Scale for ChildrenThe Sleep Hygiene Scale for Children is a short questionnaire answered by parents about behavioral sleep disorders. Total result ("sleep hygiene issue" : yes/no) and three scores (attachment parenting, translational coping, screen exposure) will be calculated, according to the classical procedures during hospitalization of all young children in our sleep unit. | Other | Infants with Down Syndrome |
Primary outcome
Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI)
Time frame: Day 1
Number of peaks during sucking bursts will be measured by non-nutritive sucking recording. OAHI will be measured by PSG.
10 secondary outcomes
Oro-facial myo-functional characteristics
Time frame: D1
Respiratory PSG indices
Time frame: Night between Day 1 and Day 2.
Subjective parental evaluation of sleep disorders on the Sleep Disturbance Scale for Children (SDSC)
Time frame: Day 1
Subjective parental evaluation of sleep hygiene on the Sleep Hygiene Scale for Children (SHSC)
Time frame: Day 1
Heart rate variability (HRV)
Time frame: Night between Day 1 and Day 2.
Electrophysiological evaluation of sucking
Time frame: Day 1
Neuropsychological evaluation
Time frame: Day 2
Quality of life on the PedsQL
Time frame: Day 1
Clinical examination of oro-facial myo-functional characteristics
Time frame: Day 2
PSG sleep architecture parameters
Time frame: Night between Day 1 and Day 2.
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 3 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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: looking for participants now, as of the sponsor's last update on 3 Apr 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 PF FRACO, MD, PhD (+33 4 27 85 60 52, 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?
Number of peaks composing sucking bursts and obstructive apnea-hypopnea index (OAHI) (time frame: Day 1). 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 3 Apr 2026.