Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
NCT Number: NCT03743558
The aim of the study is to evaluate the value of a video recording of the child sleep on smartphone made by the parents and comparing it to ventilatory polygraphy (PV) on the one hand and to the clinical evaluation method (clinical examination + Spruyt and Gozal score) on the other hand.
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Notify Me3 year–10 year
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63003, France
Obstructive sleep apnoea syndrome (OSAS) is a common disorder in school-aged children with an estimated prevalence of 1-4%. The main etiology is adeno-amygdala hypertrophy. Adenoamygdalectomy, which involves the removal of tonsils and adenoids, is a common procedure. In the majority of cases, it allows the healing of OSAS. The surgical indication is currently based on clinical arguments sensitized by the calculation of a severity score (Spruyt and Gozal score). However, this procedure is not without complications: pneumopathy (for 1.5% of procedures), blood transfusion for haemorrhage (1/400 to 1/2 500), death due to haemorrhage (1/35 000 to 1/50 000).
Currently there is no indication to perform a preoperative sleep recording for this surgery. This recording will only be made in case of associated comorbidities (obesity, craniofacial malformations, neurological disorders...).
The current growth and diffusion of smartphones in the population provides a simple technical means of video recording the child's sleep. More and more parents come to an ENT consultation with a video recording of their child's sleep on a smartphone. The current recommendations say to take these data into account without any study having evaluated the value of such records. The video recording of a snoring child's sleep has already been evaluated by Sivan et al in 1996. This study finds a good correlation between polysomnographic recording and a method of rating video recordings of sleep in children with adeno-amygdala hypertrophy without associated comorbidities.
The aim of this study is therefore to evaluate the value of this video recording on smartphone made by the parents by comparing it to ventilatory polygraphy (PV) on the one hand and to the clinical evaluation method (clinical examination + SHS score) on the other hand. If our hypothesis is correct, smartphone video recording could be an additional tool to the clinical diagnosis of OSA in children with adeno-amygdala hypertrophy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
value of a video recording of the child sleep on smartphone made by the parents
Time frame: at day 1
The primary judging criterion will be the 10-minute video analysis score (independent variable). The dependent variable will be the status obtained with PV (pathological or normal), defined according to the standard criteria of the American Academy of Sleep Medicine 2012
Time frame: at day 1
The primary judging criterion will be the 10-minute video analysis score (independent variable). The dependent variable will be the status obtained with PV (pathological or normal), defined according to the standard criteria of the American Academy of Sleep Medicine 2012
Time frame: at day 1
The secondary judging criterion will be the 10-minute video analysis score (independent variable). The dependent variable will be the status obtained with the score from the Spruyt and Gozal questionnaire (hierarchical SHS severity score) in its validated version in French.
Time frame: at day 1
The secondary judging criterion will be the 10-minute video analysis score (independent variable). The dependent variable will be the status obtained with the score from the Spruyt and Gozal questionnaire (hierarchical SHS severity score) in its validated version in French.
University Hospital, Clermont-Ferrand
Other
Acronym: SMARTSAS
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