Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children (SASDICO)
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Didgeridoo
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Didgeridoo
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
Sites / Locations
- Hôpital Robert Debré; service de Physiologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Didgeridoo
Absence
Arm Description
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.
The children will have nothing to do.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Quality of the sleep
clinical scores on Pediatric Sleep Questionnaire
Apnea
Apnea Severity Hierarchy score (SHS)
Quality of life
score OSA-18
Desaturation
Desaturation index (IDO3%)
Nocturnal saturation
McGill score
measuring the effect on the surgical indication
number of children for whom the indication for surgery was maintained at the follow-up consultation
Full Information
NCT ID
NCT05164211
First Posted
November 19, 2021
Last Updated
April 4, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05164211
Brief Title
Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children
Acronym
SASDICO
Official Title
Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children: Proof-of-concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
no inclusion since the opening of the centers (difficulties in recruiting staff which impact the functioning of the services)
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Didgeridoo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial, with minimisation criteria, single blind, bicentric
Masking
Outcomes Assessor
Masking Description
The nurse performing the rhinopharyngometry measurements does not perform the compliance calculation (primary objective). The measurements from the acoustic pharyngometry are analysed (compliance calculation) by a doctor who does not know the child's randomisation arm. Thus, if the subjects have knowledge of their randomisation group, the assessment of the primary endpoint is blinded.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Didgeridoo
Arm Type
Experimental
Arm Description
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.
Arm Title
Absence
Arm Type
No Intervention
Arm Description
The children will have nothing to do.
Intervention Type
Other
Intervention Name(s)
Didgeridoo
Intervention Description
the children will have 6 didgeridoo lessons given by a teacher spread over 3 months.
Primary Outcome Measure Information:
Title
pharyngeal compliance
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of the sleep
Description
clinical scores on Pediatric Sleep Questionnaire
Time Frame
4 months
Title
Apnea
Description
Apnea Severity Hierarchy score (SHS)
Time Frame
4 months
Title
Quality of life
Description
score OSA-18
Time Frame
4 months
Title
Desaturation
Description
Desaturation index (IDO3%)
Time Frame
4 months
Title
Nocturnal saturation
Description
McGill score
Time Frame
4 months
Title
measuring the effect on the surgical indication
Description
number of children for whom the indication for surgery was maintained at the follow-up consultation
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Plamen BOKOV, PHD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré; service de Physiologie
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children
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