- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06287333
Video-respiratory Polygraphy in Children
Video-respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Syndrome in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires the performance of a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. PSG gives the obstructive apnea-hypopnea index (OAHI) necessary for the diagnosis of OSA and to determine its severity. But PSG is a cumbersome exam, sometimes difficult to carry out in children, with several sensors and electrodes to install (electroencephalogram (EEG), myogram (EMG), occulogram (EOG), necessary to determine awakening and sleep periods and intra-sleep micro-arousals, nasal cannula, thoraco-abdominal straps, pulse oximetry, actimetry to score respiratory events). PSG is time-consuming for installation and analysis. Simplified methods of recording and analysis are preferable in children but require validation in this population.
Respiratory polygraphy (RP) which uses only respiratory signals (without EEG, EMG and EOG) can be used for the diagnosis of OSA but studies showed that it underestimated the OAHI because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not.
The hypothesis of this study is that video-RP can identify OSAS in children.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Iulia IOAN, MD PhD
- Phone Number: +33383154794
- Email: ic.ioan@chru-nancy.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children with suspicion of OSAS
- Interpretable polysomnography
Exclusion Criteria:
- Non-interpretable polysomnography
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OAHI in video-RP significantly correlated with OAHI in PSG
Time Frame: One night
|
Value of the OAHI obtained by the video-RP for each of the children in the groups with OSAS (who have an OAHI ≥ 1/h in PSG) and without OSAS (who have an OAHI < 1/h in PSG) will be correlated with the value of OAHI obtained by PSG using a Fisher exact test
|
One night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic ability of video-RP to identify OSAS in children
Time Frame: One night
|
ROC curves to determine the sensitivity and specificity of the OAHI obtained by video-RP to identify children with OSA
|
One night
|
Diagnostic ability of video-RP to identify moderate-severe OSAS in children
Time Frame: One night
|
ROC curves to determine the sensitivity and specificity of the OAHI obtained by video-RP to identify children with moderate-severe OSA (with an OAHI ≥ 5 /h in PSG)
|
One night
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Horne AF, Olafsdottir KA, Arnardottir ES. In-person vs video hookup instructions: a comparison of home sleep apnea testing quality. J Clin Sleep Med. 2022 Aug 1;18(8):2069-2074. doi: 10.5664/jcsm.10084.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023PI221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Sleep Apnea, Obstructive
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
Clinical Trials on Polysomnography in routine care
-
Peking University First HospitalBeijing Jishuitan HospitalNot yet recruitingPostoperative Delirium | Orthopedic Surgery | Treatment | Acupuncture | Older PatientsChina
-
Baqiyatallah Medical Sciences UniversityShahid Beheshti University; Tehran University of Medical SciencesCompletedVentilator-associated Pneumonia
-
Göteborg UniversityCompletedMobilization | Intensive Care (ICU)Sweden
-
University of CincinnatiCompleted
-
Cerebra MedicalUniversity of ManitobaSuspended
-
Ataturk UniversityActive, not recruitingNursing Care for Gastrointestinal Cancer PatientsTurkey
-
Pacific Coast Family Medical GroupEnrolling by invitationCancer | Atherosclerosis | Atrial Fibrillation | Insulin Resistance | Dementia | PreDiabetes | Type2 Diabetes | NASH - Nonalcoholic Steatohepatitis | Diastolic Dysfunction | Carotid Plaque
-
ADDMEDICA SASACompletedSickle Cell DiseaseFrance
-
Nova Scotia Health AuthorityAstraZeneca; Heart and Stroke Foundation of Canada; Atlantic Health Sciences... and other collaboratorsCompletedHeart FailureCanada
-
Ahmed talaat ahmed alyUnknown