Clinical trial NCT03743558: Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population
Official title: Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Adeno-amygdala Hypertrophy
Snoring
Keywords: Obstructive sleep apnea syndrome
Adeno-amygdala hypertrophy
Tonsillectomy
Video
Smartphone
Ventilatory polygraphy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: First consultation: SHS questionnaire submission and clinical examination

* Realization of PV and analysis according to the standard criteria of the American Academy of Sleep Medicine
* Production of a video at home by the parents according to the following conditions, within 4 days around the PV/PSG :
* Second consultation
* Collection of the video and the result of the PV
* Study exit.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Video analysis score
timeFrame: at day 1
measure: status obtained with PV
timeFrame: at day 1
Secondary outcomes:
measure: Video analysis score
timeFrame: at day 1
measure: score from the Spruyt and Gozal questionnaire
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Nicolas SAROUL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pateron B, Marianowski R, Monteyrol PJ, Couloigner V, Akkari M, Chalumeau F, Fayoux P, Leboulanger N, Franco P, Mondain M. French Society of ENT (SFORL) guidelines (short version) on the roles of the various treatment options in childhood obstructive sleep apnea-hypopnea syndrome. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Aug;135(4):265-268. doi: 10.1016/j.anorl.2018.04.005. Epub 2018 May 3.
citation: Spruyt K, Gozal D. Screening of pediatric sleep-disordered breathing: a proposed unbiased discriminative set of questions using clinical severity scales. Chest. 2012 Dec;142(6):1508-1515. doi: 10.1378/chest.11-3164.
citation: Nguyen XL, Levy P, Beydon N, Gozal D, Fleury B. Performance characteristics of the French version of the severity hierarchy score for paediatric sleep apnoea screening in clinical settings. Sleep Med. 2017 Feb;30:24-28. doi: 10.1016/j.sleep.2016.01.021. Epub 2016 Mar 14.
citation: Sivan Y, Kornecki A, Schonfeld T. Screening obstructive sleep apnoea syndrome by home videotape recording in children. Eur Respir J. 1996 Oct;9(10):2127-31. doi: 10.1183/09031936.96.09102127.
citation: Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.