Home Respiratory Polygraphy in Childhood Sleep Apnea-Hypopnea Syndrome (CHILDSLEEP). (CHILDSLEEP)

Usefulness of Home Respiratory Polygraphy in the Diagnosis and Therapeutic Decision of Childhood Sleep Apnea-Hypopnea Syndrome

The aims of the study is to assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.

Methods: Children referred with suspected OSAS will be evaluated during one year performing home respiratory polygraphy in all cases. PSG will be chosen in patients with concomitant pathology or according to medical criteria, or complemented with HRP in doubtful cases. Clinical and anthropometric data, severity, technical quality and treatment will be obtained. Patients will be divided in two groups (HRP vs PSG) and compared, and the accuracy from HRP to establish a therapeutic decision it wil calculated. The investigator's hypothesis is that PSG should be recommended only for complex or doubtful cases.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea; Polysomnography; Home Respiratory Polygraphy Sleep Study; Childhood Sleep Apnea; Therapeutic Decision
• Intervention / Treatment: Diagnostic test: Home respiratory polygraphy

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Eusebi Chiner Vives, MD, PhD; Phone Number: 609017275; Email: echinervives@gmail.com

Study Locations

• Spain
  • Alicante
    • San Juan de Alicante, Alicante, Spain, 03550
      • Recruiting
      • Eusebio Chiner Vives
      • Contact: Eusebi Chiner-Vives, MD, PhD; Phone Number: +34699445131; Email: echinervives@gmail.com
      • Sub-Investigator: Cistina Cánovas-Galindo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children submited to Pneumology Service with sleep apnea suspicion

Description

Inclusion Criteria:

• Sleep apnea suspicion

Exclusion Criteria:

• Other sleep conditions
• Non valid home respiratory polygraphy and non valid polysomnography in the same patient
• Non informated consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Home respiratory poligraphy; Group A: Children between 4 and 14 years-old with initial OSA suspicion there will be allocated to Home Respiratory Polygraphy (HRP)	Diagnostic test: Home respiratory polygraphy; Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission; Other Names: Polysomnography
Polysomnography; Group B: Children between 4 and 14 years-old with initial OSA suspicion and concommitant diseases and false negative suspicion from HRP there will allocated to Hospital Nocturnal Polysomnography	Diagnostic test: Home respiratory polygraphy; Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission; Other Names: Polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the diagnostic utility of home respiratory polygraphy (HRP) complemented with polysomnography (PSG) in childhood Obstructive Sleep Apnea-Hypopnea Syndrome (OSAS), as well as its usefulness in the therapeutic decisions.	False negative and true positive diagnosis by home respiratory polygraphy	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations	Number of chlidhood sleep consultations related to adult consultations	two years

Collaborators and Investigators

• Sponsor: Hospital Universitario San Juan de Alicante
• Investigators: Principal Investigator: Eusebi Chiner Vives, Hospital Universitario San Juan de Alicante

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): April 6, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Sleep apnea syndrome; Childhood sleep apnea; Obstructive apnea syndrome; Obstructive apnea sleep
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: CEIC (HUSJ-20-003)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Scientific publication, Sleep spanish network
• IPD Sharing Time Frame: 5 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No