Oximetry in Children for Sleep Apnea Diagnosis

Obstructive Sleep Apnea Clinical Trial

Official title:

Oximetry for Diagnosis of Obstructive Sleep Apnea Syndrome in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05634096
• Other study ID #: 2022PI161-318
• Status: Not yet recruiting
• Start date: January 2, 2023
• Est. completion date: January 15, 2023

Study information

• Verified date: December 2022
• Source: Central Hospital, Nancy, France
• Contact: Iulia IOAN, MD PhD
• Phone: +33383154794
• Email: ic.ioan[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 950
• Est. completion date: January 15, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Oximetry
Children underwent oximetry simultaneously with video-polygraphy or video-polysomnography in routine clinical practice. The data are retrospectively collected from the patient's recording.

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

Kaditis A, Kheirandish-Gozal L, Gozal D. Pediatric OSAS: Oximetry can provide answers when polysomnography is not available. Sleep Med Rev. 2016 Jun;27:96-105. doi: 10.1016/j.smrv.2015.05.008. Epub 2015 Jun 4. — View Citation

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. — View Citation

Trucco F, Rosenthal M, Bush A, Tan HL. The McGill score as a screening test for obstructive sleep disordered breathing in children with co-morbidities. Sleep Med. 2020 Apr;68:173-176. doi: 10.1016/j.sleep.2019.12.010. Epub 2019 Dec 28. — View Citation

Van Eyck A, Lambrechts C, Vanheeswijck L, Van Hoorenbeeck K, Haentjens D, Boudewyns A, De Winter BY, Van Gaal L, De Backer W, Verhulst SL. The role of nocturnal pulse oximetry in the screening for obstructive sleep apnea in obese children and adolescents. Sleep Med. 2015 Nov;16(11):1409-1412. doi: 10.1016/j.sleep.2015.07.023. Epub 2015 Aug 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )	Baseline
Secondary	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).	Baseline