Clinical trial NCT05164211: Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children
Official title: Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children: Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Didgeridoo
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial, with minimisation criteria, single blind, bicentric
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: pharyngeal compliance
timeFrame: 4 months
Secondary outcomes:
measure: Quality of the sleep
timeFrame: 4 months
measure: Apnea
timeFrame: 4 months
measure: Quality of life
timeFrame: 4 months
measure: Desaturation
timeFrame: 4 months
measure: Nocturnal saturation
timeFrame: 4 months
measure: measuring the effect on the surgical indication
timeFrame: 5 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré; service de Physiologie
Study officials:
affiliation: APHP
name: Plamen BOKOV, PHD
role: PRINCIPAL_INVESTIGATOR
References: