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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03743558
Acronym
SMARTSAS
Enrollment
56
Registered
2018-11-16
Start date
2019-02-13
Completion date
2022-05-11
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adeno-amygdala Hypertrophy, Obstructive Sleep Apnea Syndrome, Snoring

Keywords

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

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.

Interventions

BEHAVIORALsmartphone homemade video

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Video analysis scoreat day 1The 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 PVat day 1The 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

MeasureTime frameDescription
Video analysis scoreat day 1The 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 questionnaireat day 1The 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNicolas SAROUL

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026