Pediatric Obstructive Sleep Apnea Diagnosis by Respiratory Polygraphy

NCT06754800 | Not Yet Recruiting

• 1 other identifier: 2024PI033
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory polygraphy (RP) can be used to detect obstructive sleep apnea syndrome in children (OSA) , but it underestimates the obstructive apnea-hypopnea index (OAHI) because hypopneas associated with cortical arousals are not evaluated. To compensate for this disadvantage, hypopneas linked with autonomic micro-arousals can be calculated from the drop in pulse wave amplitude (obtained dy oximetry), as increased respiratory efforts are related to autonomic nervous system activation, tachycardia, and elevated blood pressure. The aim of this study is to compare OAHI obtained by RP alone or by RP considering hypopneas associated with autonomic micro-arousals with OAHI by polysomnography (PSG).

Conditions

Sleep Apnea, Obstructive

Keywords

child; polysomnography; polygraphy; autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• OAHI in RP including hypopneas associated with autonomic micro-arousals correlated with OAHI by PSG

  Value of OAHI in RP including hypopneas associated with autonomic micro-arousals obtained by 3 algorithms (3 values of OAHI) correlated with OAHI by PSG

  A single night

Secondary Outcomes (3)

• Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose OSA reported to PSG

  A single night

• Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose moderate-severe OSA reported to PSG

  A single night

• Determine the best of the 3 algorithms that better correlates with OAHI by PSG

  A single night

Interventions

Polysomnography in routine care DIAGNOSTIC_TEST

Children performed a polysomnography in routine clinical care

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 2 to 19 years adressed for a PSG in routine clinical care for suspicion of OSA by th ear-nose-throat physician, pediatric pulmonologist, sleep specialist, endocrtinologist, genetician

You may qualify if:

• Children with suspicion of OSA
• Interpretable polysomnography

You may not qualify if:

• Non-interpretable polysomnography

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Hospital of Nancy

Nancy, 54000, France

Location

Related Publications (2)

• Grote L, Zou D, Kraiczi H, Hedner J. Finger plethysmography--a method for monitoring finger blood flow during sleep disordered breathing. Respir Physiol Neurobiol. 2003 Jul 16;136(2-3):141-52. doi: 10.1016/s1569-9048(03)00090-9.

  PMID: 12853006 BACKGROUND

• Haba-Rubio J, Darbellay G, Herrmann FR, Frey JG, Fernandes A, Vesin JM, Thiran JP, Tschopp JM. Obstructive sleep apnea syndrome: effect of respiratory events and arousal on pulse wave amplitude measured by photoplethysmography in NREM sleep. Sleep Breath. 2005 Jun;9(2):73-81. doi: 10.1007/s11325-005-0017-y.

  PMID: 15875228 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

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)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: January 1, 2025
• Study Start: December 22, 2024
• Primary Completion: December 28, 2024
• Study Completion: January 6, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)