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

NCT ID: NCT03743558

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2022-05-11

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Syndrome Adeno-amygdala Hypertrophy Snoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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children with adenoamygdala hypertrophy

Group Type EXPERIMENTAL

smartphone homemade video

Intervention Type BEHAVIORAL

value of a video recording of the child sleep on smartphone made by the parents

Interventions

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smartphone homemade video

value of a video recording of the child sleep on smartphone made by the parents

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas SAROUL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29731297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22677350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28215255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8902478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23066376 (View on PubMed)

Other Identifiers

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2018-A00435-50

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-414

Identifier Type: -

Identifier Source: org_study_id

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