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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Other: Didgeridoo

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Plamen BOKOV, PHD; Phone Number: +33 01 40 03 27 56; Email: plamen.bokov@aphp.fr
• Study Contact Backup: Name: Christophe DELCLAUX, PHD; Phone Number: +33 01 40 03 41 90; Email: christophe.delclaux@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Hôpital Robert Debré; service de Physiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Didgeridoo; the children will have 6 didgeridoo lessons given by a teacher spread over 3 months.
No Intervention: Absence; The children will have nothing to do.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Plamen BOKOV, PHD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Didgeridoo
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: APHP201130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No