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TerminatedNCT03743558SMARTSASUpdated Aug 6, 2026

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

An interventional study of smartphone homemade video in Obstructive Sleep Apnea Syndrome, Adeno-amygdala Hypertrophy and Snoring, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

Why this study was terminated
difficulty of recrutement
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
3 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea Syndrome
  • Adeno-amygdala Hypertrophy
  • Snoring

Keywords

  • Obstructive sleep apnea syndrome
  • Adeno-amygdala hypertrophy
  • Tonsillectomy
  • Video
  • Smartphone
  • Ventilatory polygraphy
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's enrollment of 56 is close to the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Chronic cardiovascular, neurological, metabolic (overweight, obesity) or associated pulmonary pathology.
  • Syndromic craniofacial malformations.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    children with adenoamygdala hypertrophy

    Behavioral: smartphone homemade video

Interventions

  • Behavioralsmartphone homemade video

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at day 1

  2. 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

    Time frame: at day 1

Secondary outcomes

  1. 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.

    Time frame: at day 1

  2. 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.

    Time frame: at day 1

07

Study locations

1 site
  • Chu Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

Publications

  • 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. PubMed 29731297 ↗
  • 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. PubMed 22677350 ↗
  • 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. PubMed 28215255 ↗
  • 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. PubMed 8902478 ↗
  • 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. PubMed 23066376 ↗
  • Saroul N, Petersen JE, Lambert C, Massoubre J, Marianowski R, Puechmaille M, Mondain M, Gilain L, Mom T, Akkari M. Pediatric obstructive sleep apnea diagnosis using a smartphone home sleep video score. Eur Ann Otorhinolaryngol Head Neck Dis. 2026 Jun 13:S1879-7296(26)00116-X. doi: 10.1016/j.anorl.2026.03.009. Online ahead of print. PubMed 42288468 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03743558
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
Feb 13, 2019
Primary completion
May 11, 2022
Completion
May 11, 2022
Last update
Aug 6, 2026

Study contacts

Nicolas SAROUL
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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