Obstructive Sleep Apnea of ChildPERSIST-B-RCTNCT06634264
Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
A study testing Soft Oral Appliance in people with Obstructive Sleep Apnea of Child and Sleep-Disordered Breathing, run by Université de Montréal at 1 site in Canada.
Trial summary
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea, usually performed after adenotonsillectomy. This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (using a flexible oral appliance) compared to nasal hygiene alone (control… Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child, Sleep-Disordered Breathing, Adenotonsillar Hypertrophy
- What is being tested?
- Soft Oral Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2024to 31 Mar 2027
- Phase
- Interventional
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- participants must:
- present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the Pediatric Sleep Questionnaire (PSQ) , greater than or equal to 0.33- This questionnaire comprises twenty-two Questions and has a good sensitivity (83%) and specificity (87%) in screening for pediatric sleep apnea.
- be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more).
Who cannot join
- participants should not:
- present with a craniofacial syndrome nor a severe medical condition with complex medical management,
- present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)
- receive orthodontic therapy during the study
- have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion.
- A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nelly Huynh, PhD contact
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte Justine, Université de Montréal
Montreal, Quebec
Nelly Huynh, PhD, 514-343-6111 ext. 3439, nelly.huynh@umontreal.ca
About this study
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea, usually performed after adenotonsillectomy.
This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (using a flexible oral appliance) compared to nasal hygiene alone (control group), in a population of children scheduled for adenotonsillectomy.
Read the detailed description
Paediatric Obstructive Sleep Apnea (PedOSA) is a multifactorial condition, associated with significant comorbidities, affecting cardiovascular health, cognitive development and quality of life. Its main cause is adenotonsillar hypertrophy, but some co-factors such as obesity, orofacial dysfunctions and craniofacial abnormalities contribute to the severity of symptoms or their persistance after adeno-tonsillectomy.
Aim : Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes (AHI) of children, and can serve as an adjunct to other therapies, but the level of compliance is a limiting factor. The investigator's aim is to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (a flexible oral appliance) in a group a children scheduled for adeno-tonsillectomy (in association with nasal hygiene) and to compare them with nasal hygiene alone (control group).
Methods : The design of the study is a randomized Controlled Trial, enrolling 60 children with significant obstructive sleep apnea and divided into 2 groups : Group 1 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 2 using nasal hygiene alone (control group). The objective assessment of sleep parameters is performed at home using an ambulatory device (AHI, desaturation index, minimal oxygen saturation, flow limitation, snoring), before and after therapy, in a 3-month interval. An orthodontic and craniofacial assessment, the examination of orofacial functions and tongue/lip strength measurements (IOPI system), as well as quality of life questionnaires (OSA-18) are also performed on participants, before and after therapy.
- Being tested
- Soft Oral Appliance
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Oral ApplianceDevice
Also called Passive Oral Myofunctional Therapy with soft oral appliance, Oral Trainer
Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Soft Oral Appliance) | Experimental | Parents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth. Receives: Device: Soft Oral Appliance |
| Control Arm (Nasal Hygiene) | No intervention | Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of apnea and hypopnea/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children.
Measured: Baseline, after 3 months of intervention, then 3 months after surgery
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of oxygen desaturation per hour/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (oximetry).
Measured: Baseline, after 3 months of intervention, then 3 months after surgery
Sleep Parameters Changes : Flow Limitation index
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of flow limitations per hour , in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (nasal canula or thermistance).
Measured: Baseline, after 3 months of intervention, then 3 months after surgery
Secondary outcomes (2)
Oral muscles strength
Lip and Tongue strength and endurance measurement with the IOPI measurement system: Measurement of Anterior and Posterior tongue elevation strength (kPa), Lip Seal strength (kPa)
Measured: Baseline, after 3 months of intervention, then 3 months after surgery
Reported quality of life
OSA 18 Questionnaire, consisting of a 18-items score and Visual Analog scale (from 0 to 10), filled by parents.
Measured: Baseline, after 3 months of intervention, then 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start20 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of ChildStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children with a sleep study positive for Obstructive Sleep Apnea would be randomized in the intervention arm (flexible oral appliance) or control group (nasal hygiene). They will be followed in parallel groups for 3 months before another sleep study/clinical examination (pre surgical) and once again after surgery ( post surgical sleep study/clinical examination).
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Nelly Huynh, Université de Montréal
- Investigators
- Nelly Huynh, PhD, Principal investigator, St. Justine's HospitalJulia Cohen-Levy, DDSMscPhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634264
- Sponsor's protocol ID
- A00-M09-24B (23-12-087)
- Acronym
- PERSIST-B-RCT
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06634264
- Acronym / sponsor ID
- PERSIST-B-RCT / A00-M09-24B (23-12-087)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Oct 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.
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea, usually performed after adenotonsillectomy.
This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (using a flexible oral appliance) compared to nasal hygiene alone (control group), in a population of children scheduled for adenotonsillectomy.
Detailed description
Paediatric Obstructive Sleep Apnea (PedOSA) is a multifactorial condition, associated with significant comorbidities, affecting cardiovascular health, cognitive development and quality of life. Its main cause is adenotonsillar hypertrophy, but some co-factors such as obesity, orofacial dysfunctions and craniofacial abnormalities contribute to the severity of symptoms or their persistance after adeno-tonsillectomy.
Aim : Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes (AHI) of children, and can serve as an adjunct to other therapies, but the level of compliance is a limiting factor. The investigator's aim is to evaluate the effectiveness of Passive Oral Myofunctional Reeducation (a flexible oral appliance) in a group a children scheduled for adeno-tonsillectomy (in association with nasal hygiene) and to compare them with nasal hygiene alone (control group).
Methods : The design of the study is a randomized Controlled Trial, enrolling 60 children with significant obstructive sleep apnea and divided into 2 groups : Group 1 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 2 using nasal hygiene alone (control group). The objective assessment of sleep parameters is performed at home using an ambulatory device (AHI, desaturation index, minimal oxygen saturation, flow limitation, snoring), before and after therapy, in a 3-month interval. An orthodontic and craniofacial assessment, the examination of orofacial functions and tongue/lip strength measurements (IOPI system), as well as quality of life questionnaires (OSA-18) are also performed on participants, before and after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Children with a sleep study positive for Obstructive Sleep Apnea would be randomized in the intervention arm (flexible oral appliance) or control group (nasal hygiene). They will be followed in parallel groups for 3 months before another sleep study/clinical examination (pre surgical) and once again after surgery ( post surgical sleep study/clinical examination).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Soft Oral Appliance) | Experimental | Device: Soft Oral ApplianceParents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth. |
| Control Arm (Nasal Hygiene) | No intervention | –Parents and Participants of this group will be reminded the nasal hygiene procedures (depending on the site; for example application of saline in each nostril three times a day,few simple breathing exercises), and given a diary to report daily use. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the Pediatric Sleep Questionnaire (PSQ) , greater than or equal to 0.33- This questionnaire comprises twenty-two Questions and has a good sensitivity (83%) and specificity (87%) in screening for pediatric sleep apnea.
- be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more).
Key exclusion criteria (6 listed)
- present with a craniofacial syndrome nor a severe medical condition with complex medical management,
- present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)
- receive orthodontic therapy during the study
- have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion.
- A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study.
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 |
|---|---|---|
| Soft Oral ApplianceAlso: Passive Oral Myofunctional Therapy with soft oral appliance, Oral TrainerOra-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support. | Device | Intervention Arm (Soft Oral Appliance) |
Primary outcome
Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI
Time frame: Baseline, after 3 months of intervention, then 3 months after surgery
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of apnea and hypopnea/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children.
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Time frame: Baseline, after 3 months of intervention, then 3 months after surgery
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of oxygen desaturation per hour/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (oximetry).
Sleep Parameters Changes : Flow Limitation index
Time frame: Baseline, after 3 months of intervention, then 3 months after surgery
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of flow limitations per hour , in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (nasal canula or thermistance).
2 secondary outcomes
Oral muscles strength
Time frame: Baseline, after 3 months of intervention, then 3 months after surgery
Reported quality of life
Time frame: Baseline, after 3 months of intervention, then 3 months after surgery
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 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Nelly Huynh, PhD contact
Nelly Huynh, PhD principal investigator
St. Justine's Hospital
Julia Cohen-Levy, DDSMscPhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Oral Appliance in people with Obstructive Sleep Apnea of Child and Sleep-Disordered Breathing, run by Université de Montréal at 1 site in Canada.
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 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 9 Oct 2024. 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 Canada. 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 Julia Cohen-Levy, DDSMscPhD (4385021890, julia.cohen-levy@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Parameters Changes : Respiratory Events Index per hour (REI) and Obstructive REI (time frame: Baseline, after 3 months of intervention, then 3 months after surgery). The study lists 3 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 9 Oct 2024.