Oximetry in Children for Sleep Apnea Diagnosis

NCT05634096 | Unknown

• 1 other identifier: 2022PI161-318
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep; Child; Polysomnography; Polygraphy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and specificity of desaturation index

  Baseline

Interventions

Oximetry DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Children with non-interpretable recordings

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related 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.

  PMID: 26146027 BACKGROUND

• 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.

  PMID: 22926173 BACKGROUND

• 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.

  PMID: 26498244 BACKGROUND

• 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.

  PMID: 32044554 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Iulia IOAN, MD PhD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iulia IOAN, MD PhD

CONTACT

+33383154794; ic.ioan@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Lung Function Department, Associate Professor

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 1, 2022
• Study Start: January 2, 2023
• Primary Completion: January 3, 2023
• Study Completion: January 15, 2023
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

FR (1)