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NCT04340310 Clinical Trial

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

Sleep Apnea Clinical Trial

— CHILDSLEEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04340310
Other study ID # CEIC (HUSJ-20-003)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2019
Est. completion date April 6, 2022

Study information
Verified date April 2020
Source Hospital Universitario San Juan de Alicante
Contact Eusebi Chiner Vives, MD, PhD
Phone 609017275
Email echinervives@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 125
Est. completion date April 6, 2022
Est. primary completion date December 20, 2021
Accepts healthy volunteers
Gender All
Age group 4 Years to 14 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Home respiratory polygraphy
Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission

Locations
Country Name City State
Spain Eusebio Chiner Vives San Juan de Alicante Alicante

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario San Juan de Alicante

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To assess the prevalence of childhood sleep apnea in Pneumology hospital consultations Number of chlidhood sleep consultations related to adult consultations two years
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