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a RCT was started
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| Name | Class |
|---|---|
| St. Justine's Hospital | OTHER |
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Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible oral appliance, both in combination with nasal hygiene), compared to nasal hygiene alone (control group).
Introduction: Paediatric Obstructive Sleep Apnea (OSA) 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 two methods of oral reeducation 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 3 groups : Group 1 following daily oral exercises (+nasal hygiene), Group 2 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 3 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 months 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myofunctional Oral Exercices | Active Comparator | Parents and participants of this group will receive instructions for nasal and oral myo-functional exercises, to perform at home each day, for 5 to 10 minutes. A booklet (measure of adherence) and an Phone application for Android/Apple with descriptions/videos of those exercices will be given to them. These exercises will include nasal hygiene procedures, nasal cartilage exercices, lingual posture rehabilitation exercises, lip tone enhancement exercises, and swallowing rehabilitation exercises. |
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| 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. |
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| Control Group | No Intervention | Parents and Participants of this group will be reminded the nasal hygiene procedures (application of saline in each nostril three times a day), and given a diary to report daily use. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Myofunctional Therapy with exercices | Procedure | Oral-Motor training of oral muscles (tongue, lips) associated with nasal hygiene with daily repetition of exercices and parental support. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Parameters Changes : Apnea Hypopnea Index (AHI) | 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. | Baseline and 3 months |
| 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). | Baseline and 3 months |
| 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). | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 3 months |
| Nasal Resistance |
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Inclusion Criteria: participants must:
Exclusion Criteria: participants should not:
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| Name | Affiliation | Role |
|---|---|---|
| Nelly Huynh, PhD | Université de Montréal, Montréal, Québec, Canada | Principal Investigator |
| Marie-Claude Quintal, MD | Hôpital Sainte-Justine, Montréal, QC, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sainte Justine, Université de Montréal | Montreal | Canada |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020247 | Myofunctional Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Oral Myofunctional Therapy with soft oral appliance | Procedure | Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support. |
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Nasal resistance measurements with a anterior rhino-manometry : effective resistance left nostril (expiration, inspiration), effective resistance right nostril Pa/cm3/s during expiration, inspiration) ,total breath resistance (Pa/cm3/s during expiration, inspiration), vertex resistance right, vertex resistance left (Pa/cm3/s during inspiration, expiration).
| Baseline and 3 months |
| Quality of Life | OSA 18 Questionnaire, consisting of a 18-items score and Visual Analog scale (from 0 to 10), filled by parents. | Baseline and 3 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D003813 | Dentistry |