Skip to content

Diagnostic of Sleep Obstructive Apnea Syndrome in Children

Diagnostic of Sleep Obstructive Apnea Syndrome in Children by Home Sleep Studies

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05575921
Enrollment
44
Registered
2022-10-12
Start date
2022-10-10
Completion date
2022-10-30
Last updated
2022-10-12

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

Conditions

Apnea, Obstructive Sleep

Keywords

Sleep apnea, Child, Polysomnography

Brief summary

Obstructive Sleep Apnea Syndrome (OSAS) in children is a significant public health problem whose clinical diagnosis is not specific. The recording of sleep and breathing (polysomnography, PSG) is the reference exam. PSG consists in installing on the child's body electrodes necessary to determine the sleep stages and sensors used to determine the presence of respiratory events during sleep. At-home PSG, compared to hospital PSG, improves sleep quality. PSG is yet an anxious exam due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only respiratory detectors. The objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG.

Detailed description

Obstructive Sleep Apnea Syndrome (OSAS) in children causes chronic hematosis disorders and sleep disruption that negatively impacts growth, neurocognitive performance, and cardiovascular and metabolic functions. Its high frequency makes it a major public health problem. The clinical elements for the diagnosis are not specific and the recording of sleep and breathing (polysomnography, PSG) is the reference exam (HAS Recommendations, 2012). PSG consists in installing on a child's body electroencephalogram (EEG), electrooculogram (EOG), and electromyogram (EMG) electrodes, necessary to determine the sleep stages and sleep-wake periods, and also the sensors used to determine the presence of respiratory events during sleep such as a nasal cannula, thoracoabdominal belts, oximetry, and actimetry. At-home PSG, compared to hospital PSG, improves sleep quality and diagnostic conditions. But the PSG remains a rather anxious exam for the child due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only the respiratory detectors (nasal cannula, thoracoabdominal belts, oximetry, and actimetry), without the EEG, EOG, and EMG electrodes. Several studies in the literature have compared these 2 exams, PSG and PG, for diagnosing OSAS in children with varied and sometimes contradictory results. 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.

Interventions

DIAGNOSTIC_TESTPolysomnography

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years

Inclusion criteria

* Data from at-home PSG retrospectively collected from the hospital recording of children who underwent an exam during the period October 2020 to March 2021

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
At-home PG has the same diagnostic value than at-home PSGOne nightOAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG

Secondary

MeasureTime frameDescription
At-home PSG faisability1 hourTo determine the faisability in terms of the percentage of interpretable exam for at-home PSG

Contacts

Primary ContactIulia-Cristina IOAN, MD PhD
ic.ioan@chru-nancy.fr+33383154794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026