Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children

Study Overview
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Brief Summary
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The therapeutic management of Obstructive Sleep Apnoea Syndrome in children remains a debated subject, only otorhinolaryngology surgery (adenoidectomy) has been studied on a large scale. Pathophysiologically, increased pharyngeal collapsibility is a major endotype of the disease and the investigators have shown that this surgery can improve pharyngeal compliance. The development of approaches to treat pharyngeal hypotonia by maxillofacial rehabilitation supports the treatment of this endotype. A study in adults showed a benefit from playing the didgeridoo, a wind instrument, for 3 months, without pathophysiological explanation. The investigators hypothesise that playing this instrument improves pharyngeal compliance (re-education effect) in a similar way to the effect observed after otorhinolaryngology surgery. This proof-of-concept study aims to demonstrate the effect of didgeridoo in children without syndromic pathology with a formal otorhinolaryngology surgical indication resulting from tonsillar hypertrophy (Brodsky grades III and IV) and symptomatology suggestive of Obstructive Sleep Apnoea Syndrome (Pediatric Sleep Questionnaire score ≥ 0.33). The investigators will take advantage of the long delay in performing the adenoidectomy ( 6 months) in their university hospital to evaluate, before the scheduled surgery, the effect of the didgeridoo used for three months.

Detailed Description
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Randomised controlled trial, with minimisation criteria, single blind, bicentric. The subjects will be divided into 2 groups, according to the strategy of care before the date of the scheduled surgery: 1. Abstention (routine care) 2. Didgeridoo rehabilitation. The primary objective is to improve pharyngeal compliance measured non-invasively by acoustic pharyngometry in the didgeridoo arm compared to a no treatment arm. The secondary objectives are to demonstrate the effect of the didgeridoo on clinical signs associated with Obstructive Sleep Apnoea Syndrome and on an indirect index of apnea-hypopnea during sleep.

Official Title
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Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children: Proof-of-concept Study

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Other: Didgeridoo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clear tonsillar hypertrophy (Brodsky grade III to IV), justifying surgery Pediatric Sleep Questionnaire ≥ 0.33 Discontinuation of any prescribed medication for Obstructive Sleep Apnea Syndrome (anti-histamine and montelukast) Access to the Didgeridoo course Consent of the holders of parental authority and agreement of the child Exclusion Criteria: Syndromic pathology Lack of affiliation to a social security scheme Holders of parental authority under guardianship or curatorship

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial, with minimisation criteria, single blind, bicentric
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Didgeridoo<br>The children will have 6 didgeridoo lessons given by a teacher spread over 3 months.They will have a didgeridoo at home to practice with. | Other: Didgeridoo<br>* the children will have 6 didgeridoo lessons given by a teacher spread over 3 months.<br>|
| No Intervention: Absence<br>The children will have nothing to do. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal compliance | measurement of pharyngeal compliance by acoustic pharyngometry carried out in the sitting and lying position. The associated measurement of the neck circumference (cm) allows the calculation of the pharyngeal compliance in cm3.kPa-1 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the sleep | clinical scores on Pediatric Sleep Questionnaire | 4 months | 
| Apnea | Apnea Severity Hierarchy score (SHS) | 4 months | 
| Quality of life | score OSA-18 | 4 months | 
| Desaturation | Desaturation index (IDO3%) | 4 months | 
| Nocturnal saturation | McGill score | 4 months | 
| measuring the effect on the surgical indication | number of children for whom the indication for surgery was maintained at the follow-up consultation | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Didgeridoo