Health TrialsbyHealthPanel

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

ConditionsObstructive Sleep ApneaDown Syndrome (Trisomy 21)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-38
SponsorHospices Civils de Lyon

About this trial

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)).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Group 1 (infants with CURAPROX pacifier)

Diagnosed with mosaic trisomy 21

Born preterm (gestation age at birth <37 weeks)

Known allergy to silicone

Trial design

Design model

Parallel

Treatments tested in this trial

  • CURAPROX pacifier use

    Device

    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 diary

    Other intervention

    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 OSA

    Diagnostic 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 recording

    Other intervention

    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 evaluation

    Other intervention

    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 evaluation

    Behavioral

    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 Children

    Other intervention

    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 Children

    Other intervention

    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-Infants

    Other intervention

    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).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Infants with Down Syndrome without CURAPROX pacifierNo intervention 0 interventions
Group B: Infants with Down Syndrome with the CURAPROX pacifierExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: