Diagnostic of Sleep Obstructive Apnea Syndrome in Children
NCT ID: NCT05575921
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
44 participants
OBSERVATIONAL
2022-10-10
2022-10-30
Brief Summary
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The objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG.
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Detailed Description
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The hypothesis of the study is that the obstructive apnea-hypopnea index (OAHI, the number of apneas, and obstructive hypopneas per hour) obtained by at-home PSG and the OAHI obtained by at-home PG are not different. For this, the sleep physician will analyze the sleep recording performed at home in routine clinical practice, in 2 ways: 1) by determining the sleep stages and computing OAHI per hour of sleep; 2) by removing EEG, EOG, and EMG signals and computing OAHI over the duration of the sleep estimated by the physician according to child's behavior during sleep (movements, artifacts) as in PG.
The main objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG, i.e. OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG. The second objective is to determine the faisability in terms of the percentage of interpretable exams of at-home PSG.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Polysomnography
Children underwent at-home polysomnography in routine clinical practice. The exam is interpreted in 2 ways by the physician with sleep stages (PSG) and without sleep stages (PG). The data are retrospectively collected from the patient's recording
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Dr. Iulia IOAN
MD PhD Associate Professor
Central Contacts
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References
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Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
Masoud AI, Patwari PP, Adavadkar PA, Arantes H, Park C, Carley DW. Validation of the MediByte Portable Monitor for the Diagnosis of Sleep Apnea in Pediatric Patients. J Clin Sleep Med. 2019 May 15;15(5):733-742. doi: 10.5664/jcsm.7764.
Lesser DJ, Haddad GG, Bush RA, Pian MS. The utility of a portable recording device for screening of obstructive sleep apnea in obese adolescents. J Clin Sleep Med. 2012 Jun 15;8(3):271-7. doi: 10.5664/jcsm.1912.
Massicotte C, Al-Saleh S, Witmans M, Narang I. The utility of a portable sleep monitor to diagnose sleep-disordered breathing in a pediatric population. Can Respir J. 2014 Jan-Feb;21(1):31-5. doi: 10.1155/2014/271061. Epub 2013 Sep 30.
Other Identifiers
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2022PI145-309
Identifier Type: -
Identifier Source: org_study_id
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