Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children
- Conditions
- Obstructive Sleep Apnea Syndrome
- Interventions
- Other: Didgeridoo
- Registration Number
- NCT05164211
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Syndromic pathology
- Lack of affiliation to a social security scheme
- Holders of parental authority under guardianship or curatorship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Didgeridoo Didgeridoo 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.
- Primary Outcome Measures
Name Time Method pharyngeal compliance 4 months 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
- Secondary Outcome Measures
Name Time Method Quality of the sleep 4 months clinical scores on Pediatric Sleep Questionnaire
Apnea 4 months Apnea Severity Hierarchy score (SHS)
Quality of life 4 months score OSA-18
Desaturation 4 months Desaturation index (IDO3%)
Nocturnal saturation 4 months McGill score
measuring the effect on the surgical indication 5 months number of children for whom the indication for surgery was maintained at the follow-up consultation
Trial Locations
- Locations (1)
Hôpital Robert Debré; service de Physiologie
🇫🇷Paris, France