Obstructive Sleep Apnea SyndromeYooTETNCT06489223
Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
A study testing Orofacial Myofunctional Rehabilitation Pacifier in people with Obstructive Sleep Apnea Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome. This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test. Read more about this study
- Who is it for?
- Ages 4 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Orofacial Myofunctional Rehabilitation Pacifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant aged 4 weeks to 6 months coming to the pediatric sleep department to perform a polysomnography or polygraphy with video, during hospitalization of at least 24 hours,
- Affiliate or beneficiary of a social security scheme,
- With informed consent of the 2 legal representatives.
Who cannot join
- Known allergy to silicone.
Trial locations and contacts
1 site in 1 country.
France1 site
Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
Lyon, 69500
About this study
The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome.
This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test.
If acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of Obstructive Sleep Apnea Syndrome (OSAS) in very young children, via orofacial myofunctional rehabilitation
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Orofacial Myofunctional Rehabilitation Pacifier
- Keywords
- Obstructive Sleep Apnea Syndrome, pacifier
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orofacial Myofunctional Rehabilitation PacifierDevice
The pacifier will be offered to the child
| Study group | Role | What they receive |
|---|---|---|
| Use of an Orofacial Myofunctional Rehabilitation Pacifier | Experimental | The device will be offered to the child during waking periods during three tests which will be programmed remotely or not from a bottle. Each of this tests will last 15 minutes. Tests taking place near a meal must take place within 20 minutes before or after the bottle. The last test will be offered at bedtime with the aim of the child falling asleep with the device. Receives: Device: Orofacial Myofunctional Rehabilitation Pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the acceptability of the pacifier in the mouth while awake
cumulative time during which the pacifier is kept in the mouth over three 15-minute sessions of awake testing. The pacifier will be judged as accepted if at least 15 minutes of pacifier in the mouth are accumulated over the 3 tests carried out.
Measured: Day 1 inclusion
Secondary outcomes (4)
Evaluate the attitude of infants when taking the pacifier in the mouth
presence of grimaces when offering the pacifier in the mouth or non-nutritive sucking behavior during each test
Measured: Day 1 inclusion
Evaluate whether the pacifier is held in the mouth while awake
Number of times the child rejects the pacifier and the maximum duration of uninterrupted hold in the mouth during the 15 minutes of each test
Measured: Day 1 inclusion
Evaluate how well the pacifier stays in the mouth during sleep
Time during which the pacifier is kept in the mouth during sleep until spontaneous rejection, measured from a video recording, correlated to the parameters recorded by polysomnography (sleep efficiency, apnea-hypopnea index, number of microphones -arousals, total sleep time and sleep latency).
Measured: Day 1 inclusion, during the night
Assessment of the safety of the pacifier in infants
Recording of any adverse events
Measured: Day 1 inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start11 Dec 2024
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia FRANCO, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489223
- Sponsor's protocol ID
- 69HCL23_0811
- Acronym
- YooTET
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2024
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acceptability and Tolerance of an Orofacial Myofunctional Rehabilitation Pacifier in Infants
- ClinicalTrials.gov ID
- NCT06489223
- Acronym / sponsor ID
- YooTET / 69HCL23_0811
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive Sleep Apnea Syndrome, pacifier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 5 Jul 2024 (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.
The development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with Down syndrome.
This protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test.
If acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of Obstructive Sleep Apnea Syndrome (OSAS) in very young children, via orofacial myofunctional rehabilitation
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of an Orofacial Myofunctional Rehabilitation Pacifier | Experimental | Device: Orofacial Myofunctional Rehabilitation PacifierThe device will be offered to the child during waking periods during three tests which will be programmed remotely or not from a bottle. Each of this tests will last 15 minutes. Tests taking place near a meal must take place within 20 minutes before or after the bottle. The last test will be offered at bedtime with the aim of the child falling asleep with the device. |
Who may qualify
- Ages
- 4 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant aged 4 weeks to 6 months coming to the pediatric sleep department to perform a polysomnography or polygraphy with video, during hospitalization of at least 24 hours,
- Affiliate or beneficiary of a social security scheme,
- With informed consent of the 2 legal representatives.
Key exclusion criteria (1 listed)
- Known allergy to silicone.
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 |
|---|---|---|
| Orofacial Myofunctional Rehabilitation PacifierThe pacifier will be offered to the child | Device | Use of an Orofacial Myofunctional Rehabilitation Pacifier |
Primary outcome
assess the acceptability of the pacifier in the mouth while awake
Time frame: Day 1 inclusion
cumulative time during which the pacifier is kept in the mouth over three 15-minute sessions of awake testing. The pacifier will be judged as accepted if at least 15 minutes of pacifier in the mouth are accumulated over the 3 tests carried out.
4 secondary outcomes
Evaluate the attitude of infants when taking the pacifier in the mouth
Time frame: Day 1 inclusion
Evaluate whether the pacifier is held in the mouth while awake
Time frame: Day 1 inclusion
Evaluate how well the pacifier stays in the mouth during sleep
Time frame: Day 1 inclusion, during the night
Assessment of the safety of the pacifier in infants
Time frame: Day 1 inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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. This study is not recruiting at the moment.
Patricia FRANCO 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 Orofacial Myofunctional Rehabilitation Pacifier in people with Obstructive Sleep Apnea Syndrome, 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the acceptability of the pacifier in the mouth while awake (time frame: Day 1 inclusion). 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 13 Apr 2025.