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

March 5, 2024 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: children with adenoamygdala hypertrophy
Behavioral: smartphone homemade video
value of a video recording of the child sleep on smartphone made by the parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Video analysis score
Time Frame: at day 1
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
Time Frame: at day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Video analysis score
Time Frame: at day 1
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.
at day 1
score from the Spruyt and Gozal questionnaire
Time Frame: at day 1
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.
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Nicolas SAROUL, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2019

Primary Completion (Actual)

May 11, 2022

Study Completion (Actual)

May 11, 2022

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-414
  • 2018-A00435-50 (Other Identifier: 2018-A00435-50)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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