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

Obstructive Sleep Apnea Syndrome Clinical Trial

— SASDICO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05164211
• Other study ID #: APHP201130
• Status: Withdrawn
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• Didgeridoo
the children will have 6 didgeridoo lessons given by a teacher spread over 3 months.

Locations

Country	Name	City	State
France	Hôpital Robert Debré; service de Physiologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of the sleep	clinical scores on Pediatric Sleep Questionnaire	4 months
Secondary	Apnea	Apnea Severity Hierarchy score (SHS)	4 months
Secondary	Quality of life	score OSA-18	4 months
Secondary	Desaturation	Desaturation index (IDO3%)	4 months
Secondary	Nocturnal saturation	McGill score	4 months
Secondary	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