Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 5 Sept 2022
- Ended
- Jan 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Didgeridoo
- Record updated
- 6 April 2023
- Why it stopped
- no inclusion since the opening of the centers (difficulties in recruiting staff which impact the functioning of the services)
Who can take part
- Age
- 4 years to 12 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Syndromic pathology
- Lack of affiliation to a social security scheme
- Holders of parental authority under guardianship or curatorship
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- DidgeridooTreatment being tested
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.
- AbsenceNo study treatment, for comparison
The children will have nothing to do.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children: Proof-of-concept Study
- Record updated
- 6 April 2023