Obstructive Sleep Apnea SyndromeSAOSNCT03267927
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
A study testing Rapid palatal expansion, MGA™ system and Yoobreath™ system in people with Obstructive Sleep Apnea Syndrome, run by Rennes University Hospital at 1 site in France.
Trial summary
Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Rapid palatal expansion, MGA™ system and Yoobreath™ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2017to 25 Mar 2019
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5 to 7 year-old children
- Children with American Society of Anesthesiologists score (ASA) of 1 and 2
- Children with signs of OSA during examination and clinical exam
- Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
- Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis
Who cannot join
- OSA associated to syndromic disorder and/or syndrome
- Body/Mass Index (BMI) > 97ème percentile according to development curves (obese children)
- Central sleep apnea
- Respiratory allergy
- Previous ear, nose and throat (ENT) surgery
- Hypertrophic tonsils needing surgery
- Adenoid hypertrophy needing surgery
- Patients with ankyloglossia
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.
Read the detailed description
Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Rapid palatal expansion, MGA™ system, Yoobreath™ system
- Keywords
- OSA, Polysomnography, Rapid palatal expansion, Mandibular advancement, Sleep position
- 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.
Rapid palatal expansionDevice
Fixation of rapid palatal expansion from day 0 to day 60
MGA™ systemDevice
Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
Yoobreath™ systemDevice
Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
| Study group | Role | What they receive |
|---|---|---|
| Patient with OSA | Experimental | Not described Receives: Device: Rapid palatal expansion; Device: MGA™ system; Device: Yoobreath™ system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)
Measured: Day 180
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)
Measured: Day 180
Secondary outcomes (16)
Sleep improvement
Measurement by polysomnography of desaturation index, micro arousal index and snoring index
Measured: Day -7, day 180
Assessment of quality of sleep
Assessment of quality of sleep by a questionnaire
Measured: Day 180
Assessment of quality of wakefulness
Assessment of quality of wakefulness by a questionnaire
Measured: Day 180
Measurement of lengthening of mandibular body and ramus
Assessment of mandible development by an orthodontist using cephalometric analysis
Measured: Day -7, day 180
Improvement of breathing
Improvement of breathing defined by polysomnography
Measured: Day -7, day 180
Assessment of dental occlusion
Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class
Measured: Day -7, day 180
Assessement by the child and the parents of the treatment and the devices used
Assessement by the child and the parents of the treatment and the devices used by two questionnaires (one for parents and one for the child)
Measured: Day 180
Assessment of intensity of pain during rapid palatal expansion
Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS)
Measured: Day 60
Assessment of duration of pain during rapid palatal expansion
Number of painful days after fixing of rapid palatal expansion
Measured: Day 60
Assessment of intensity of dental pain the morning on waking after using the MGA™ system
Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS)
Measured: Day 60, day 90, day 120, day 150, day 180
Assessment of salivary disorders the morning on waking after using the MGA™ system
Assessment of salivary disorders the morning on waking by a questionnaire
Measured: Day 60, day 90, day 120, day 150, day 180
Assessment of duration of dental pain the morning on waking after using the MGA™ system
Number of painful days at the mandible the morning on waking
Measured: Day 60, day 90, day 120, day 150, day 180
Assessment of pain related to the semi-seated position
Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS)
Measured: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of disorders in falling asleep and sleep quality (micro arousals)
Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire
Measured: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of risk of falling using the Yoobreath system™
Number of falls
Measured: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of the compliance
Reporting of side effects
Measured: Day 0, day 15, day 60, day 90, day 120, day 150, day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start5 Nov 2017
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
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 Rennes University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267927
- Sponsor's protocol ID
- 35RC16_9851_SAOS
- Acronym
- SAOS
- Status last verified
- Feb 2020
- First submitted
- 28 Aug 2017
- Last updated
- 7 Feb 2020
- 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 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
- ClinicalTrials.gov ID
- NCT03267927
- Acronym / sponsor ID
- SAOS / 35RC16_9851_SAOS
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- OSA, Polysomnography, Rapid palatal expansion, Mandibular advancement, Sleep position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 31 Aug 2017 (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.
Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.
Detailed description
Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with OSA | Experimental | Device: Rapid palatal expansion, Device: MGA™ system, Device: Yoobreath™ system |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 5 to 7 year-old children
- Children with American Society of Anesthesiologists score (ASA) of 1 and 2
- Children with signs of OSA during examination and clinical exam
- Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
- Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis
Key exclusion criteria (8 listed)
- OSA associated to syndromic disorder and/or syndrome
- Body/Mass Index (BMI) > 97ème percentile according to development curves (obese children)
- Central sleep apnea
- Respiratory allergy
- Previous ear, nose and throat (ENT) surgery
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 |
|---|---|---|
| Rapid palatal expansionFixation of rapid palatal expansion from day 0 to day 60 | Device | Patient with OSA |
| MGA™ systemUse of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained) | Device | Patient with OSA |
| Yoobreath™ systemUse of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained) | Device | Patient with OSA |
Primary outcome
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)
Time frame: Day 180
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)
Time frame: Day 180
16 secondary outcomes
Sleep improvement
Time frame: Day -7, day 180
Assessment of quality of sleep
Time frame: Day 180
Assessment of quality of wakefulness
Time frame: Day 180
Measurement of lengthening of mandibular body and ramus
Time frame: Day -7, day 180
Improvement of breathing
Time frame: Day -7, day 180
Assessment of dental occlusion
Time frame: Day -7, day 180
Assessement by the child and the parents of the treatment and the devices used
Time frame: Day 180
Assessment of intensity of pain during rapid palatal expansion
Time frame: Day 60
Assessment of duration of pain during rapid palatal expansion
Time frame: Day 60
Assessment of intensity of dental pain the morning on waking after using the MGA™ system
Time frame: Day 60, day 90, day 120, day 150, day 180
Assessment of salivary disorders the morning on waking after using the MGA™ system
Time frame: Day 60, day 90, day 120, day 150, day 180
Assessment of duration of dental pain the morning on waking after using the MGA™ system
Time frame: Day 60, day 90, day 120, day 150, day 180
Assessment of pain related to the semi-seated position
Time frame: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of disorders in falling asleep and sleep quality (micro arousals)
Time frame: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of risk of falling using the Yoobreath system™
Time frame: Day 15, day 60, day 90, day 120, day 150, day 180
Assessment of the compliance
Time frame: Day 0, day 15, day 60, day 90, day 120, day 150, day 180
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 7 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid palatal expansion, MGA™ system and Yoobreath™ system in people with Obstructive Sleep Apnea Syndrome, run by Rennes University Hospital 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 8 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 7 Feb 2020. 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?
Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™) (time frame: Day 180). The study lists 2 primary outcomes in all. 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 Feb 2020.