Obstructive Sleep Apnea SyndromeSMARTSASNCT03743558
Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population
A study testing smartphone homemade video in people with Obstructive Sleep Apnea Syndrome and Adeno-amygdala Hypertrophy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Adeno-amygdala Hypertrophy, Snoring
- What is being tested?
- smartphone homemade video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2019to 11 May 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Chronic cardiovascular, neurological, metabolic (overweight, obesity) or associated pulmonary pathology.
- Syndromic craniofacial malformations.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- smartphone homemade video
- Keywords
- Obstructive sleep apnea syndrome, Adeno-amygdala hypertrophy, Tonsillectomy, Video, Smartphone, Ventilatory polygraphy
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone homemade videoBehavioural
value of a video recording of the child sleep on smartphone made by the parents
| Study group | Role | What they receive |
|---|---|---|
| children with adenoamygdala hypertrophy | Experimental | Not described Receives: Behavioral: smartphone homemade video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at day 1
Secondary outcomes (2)
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.
Measured: at day 1
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.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start13 Feb 2019
- Primary completion11 May 2022
- Study completion11 May 2022
Why it stopped: difficulty of recrutement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas SAROUL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743558
- Sponsor's protocol ID
- CHU-414
- Other IDs
- 2018-A00435-50
- Acronym
- SMARTSAS
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2018
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29731297Spruyt 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 22677350Nguyen 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 28215255Sivan 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 8902478Berry 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 23066376Saroul 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