An observational study in Obstructive Sleep Apnea, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-01-03.
Sponsored by Central Hospital, Nancy, France · Observational
Video-polygraphy or video-polysomnography (vP(S)G) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children as it allows the detection of the respiratory events presented by the child during sleep. This exam requires a one-night hospitalization and several sensors installed on the child's body, sometimes not well-accepted in children. Portable oximetry is an easier test to perform, better accepted by the child, and gives the desaturation index that may be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify a moderate-severe OSAS in children.
Video-polysomnography (vPSG) with video surveillance and monitoring by a nurse to reposition the sensors if needed during the night is the gold standard exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children. The vPSG gives the obstructive apnea-hypopnea index (OAHI), necessary for the diagnosis of OSAS and to determine its severity. But the vPSG is a rather cumbersome exam, sometimes difficult to perform in children, with several sensors and electrodes to install on a child's body (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), nasal cannula, thoracoabdominal belts, pulse oximetry, body position) that is time-consuming for installation and analysis. Video-respiratory polygraphy (vPG) is very similar to vPSG but without EEG, EOG and EMG electrodes. vPG represents an alternative for the diagnosis of OSAS. However, these sleep examinations, vP(S)G, requires a number of electrodes and sensors to be installed on the child's body and one night of hospitalization.
The desaturation index obtained by simple portable oximetry could be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. Portable oximetry is an easier test to perform. It is better accepted by the child because it only requires a finger or toe sensor and could be done on an outpatient basis or in the hospital.
The coupling of these 2 examinations, vP(S)G and oximetry, is part of our current routine practice. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify an OSAS in children.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 950 is above the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022. Data of vP(S)G and of oximetry are retrospectively collected from the hospital recording of children who underwent these exams.
Children aged 2 to 18 years suspected of OSA who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022.
Exclusion Criteria:
Children with non-interpretable recordings
Children underwent oximetry simultaneously with video-polygraphy or video-polysomnography in routine clinical practice. The data are retrospectively collected from the patient's recording.
Desaturation index is different in moderate-severe OSAS
The number of desaturations per hour of recording obtained by oximetry between children with moderate-severe OSAS (defined as OAHI ≥ 5/h of sleep on the vP(S)G) and children without OSAS/with mild OSAS (defined as OAHI \< 5/h of sleep )
Time frame: Baseline
Sensitivity and specificity of desaturation index
Sensitivity and specificity of the number of desaturations per hour if recording obtained by oximetry alone for the identification of children with moderate-severe OSAS (defined as an OAHI ≥ 5 /h of sleep in vP(S)G).
Time frame: Baseline
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France