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

NCT03743558 | Terminated

• 2 other identifiers: CHU-4142018-A00435-50
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome; Adeno-amygdala Hypertrophy; Snoring

Keywords

Obstructive sleep apnea syndrome; Adeno-amygdala hypertrophy; Tonsillectomy; Video; Smartphone; Ventilatory polygraphy

Outcome Measures

Primary Outcomes (2)

• 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

  at day 1

• 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

  at day 1

Secondary Outcomes (2)

• Video analysis score

  at day 1

• score from the Spruyt and Gozal questionnaire

  at day 1

Study Arms (1)

children with adenoamygdala hypertrophy

EXPERIMENTAL

Behavioral: smartphone homemade video

Interventions

smartphone homemade video BEHAVIORAL

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

children with adenoamygdala hypertrophy

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Chronic cardiovascular, neurological, metabolic (overweight, obesity) or associated pulmonary pathology.
• Syndromic craniofacial malformations.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (5)

• 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.

  PMID: 29731297 BACKGROUND

• 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.

  PMID: 22677350 BACKGROUND

• 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.

  PMID: 28215255 BACKGROUND

• 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.

  PMID: 8902478 BACKGROUND

• 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.

  PMID: 23066376 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas SAROUL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 16, 2018
• Study Start: February 13, 2019
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

FR (1)