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

Primary Purpose

Obstructive Sleep Apnea Syndrome, Adeno-amygdala Hypertrophy, Snoring

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
smartphone homemade video
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive sleep apnea syndrome, Adeno-amygdala hypertrophy, Tonsillectomy, Video, Smartphone, Ventilatory polygraphy

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

children with adenoamygdala hypertrophy

Arm Description

Outcomes

Primary Outcome Measures

Video analysis score
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 PV
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

Video analysis score
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 questionnaire
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.

Full Information

First Posted
November 5, 2018
Last Updated
March 16, 2021
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03743558
Brief Title
Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population
Acronym
SMARTSAS
Official Title
Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Adeno-amygdala Hypertrophy, Snoring
Keywords
Obstructive sleep apnea syndrome, Adeno-amygdala hypertrophy, Tonsillectomy, Video, Smartphone, Ventilatory polygraphy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
children with adenoamygdala hypertrophy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
smartphone homemade video
Intervention Description
value of a video recording of the child sleep on smartphone made by the parents
Primary Outcome Measure Information:
Title
Video analysis score
Description
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
Title
status obtained with PV
Description
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
Secondary Outcome Measure Information:
Title
Video analysis score
Description
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
Title
score from the Spruyt and Gozal questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas SAROUL
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Nicolas SAROUL
First Name & Middle Initial & Last Name & Degree
Jens ERIK
First Name & Middle Initial & Last Name & Degree
Mohamed AKKARI
First Name & Middle Initial & Last Name & Degree
Bruno MONPEYSSIN
First Name & Middle Initial & Last Name & Degree
Rémi MARIANOSWSKI

12. IPD Sharing Statement

Citations:
PubMed Identifier
29731297
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.
Results Reference
background
PubMed Identifier
22677350
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.
Results Reference
background
PubMed Identifier
28215255
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.
Results Reference
background
PubMed Identifier
8902478
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.
Results Reference
background
PubMed Identifier
23066376
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.
Results Reference
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Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population

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