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Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population

Not Applicable
Terminated
Conditions
Obstructive Sleep Apnea Syndrome
Adeno-amygdala Hypertrophy
Snoring
Interventions
Behavioral: smartphone homemade video
Registration Number
NCT03743558
Lead Sponsor
University Hospital, Clermont-Ferrand
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
56
Inclusion Criteria
  • Children between 3 and 10 years old consulting an ENT for snoring noted by the entourage (parents).
  • Tonsil hypertrophy ≥ 2 (Brodsky classification).
  • Entourage in possession of a smartphone allowing a video recording (under Android format).
Exclusion Criteria
  • Chronic cardiovascular, neurological, metabolic (overweight, obesity) or associated pulmonary pathology.
  • Syndromic craniofacial malformations.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
children with adenoamygdala hypertrophysmartphone homemade video-
Primary Outcome Measures
NameTimeMethod
Video analysis scoreat 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

status obtained with PVat 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

Secondary Outcome Measures
NameTimeMethod
Video analysis scoreat 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.

score from the Spruyt and Gozal questionnaireat 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.

Trial Locations

Locations (1)

Chu Clermont-Ferrand

🇫🇷

Clermont-Ferrand, France

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