Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

NCT03449550 | Completed

• 1 other identifier: PI14/01187
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the diagnostic validity and cost-effectiveness of a home respiratory polygraphy (HRP) performed at home compared with the standard polysomnography (PSG) in children with clinically suspected Obstructive Sleep Apnea (OSA).

Conditions

Obstructive Sleep Apnea

Keywords

Child obstructive sleep apnea; Home Respiratory Polygraphy; Diagnosis; Validity; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Diagnostic validity of a Home Respiratory Polygraphy (HRP)

  To establish the diagnostic validity of home respiratory polygraphy (HRP) compared with the findings obtained with polysomnography (PSG) in the sleep laboratory in children with suspected Obstructive Sleep Apnea (OSA), based on the results of Apnea-hypopnea Index (AHI)

  baseline

Secondary Outcomes (9)

• Cost effectiveness analysis

  baseline

• Validation of the therapeutic decision

  6 month

• Validity of the determination of a protein sequence in urine in OSA

  baseline

• Pediatric Sleep Questionnaire.

  baseline and at six month

• BEARS Sleep screening

  baseline and at six month

Study Arms (2)

Diagnostic Randomizing

ACTIVE COMPARATOR

Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)

Other: Home Respiratory Polygraphy (HRP); Other: Standard Polysomnography (PSG)

Therapeutic Randomizing

ACTIVE COMPARATOR

Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)

Other: Home Respiratory Polygraphy (HRP); Other: Standard Polysomnography (PSG)

Interventions

Home Respiratory Polygraphy (HRP) OTHER

Randomizing to start with home respiratory polygraphy

Also known as: Validity

Diagnostic Randomizing

Standard Polysomnography (PSG) OTHER

Randomizing to start with Standard Polysomnography (PSG)

Also known as: Validity

Diagnostic Randomizing

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 2 and 14 years of age of both sexes consecutively assessed for clinical suspicion of OSA, defined as: snoring children with observed respiratory and / or apnea pauses and / or ventilatory effort during observed sleep, and who were asked for a sleep test
• Written informed consent signed.

You may not qualify if:

• Place of residence more than 100 km from the hospital
• Psychophysical incapacity to perform the study at home
• Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
• Children with chronic insomnia and / or depressive syndrome
• Children with malformative syndromes, Down Syndrome and neuromuscular diseases
• Complete or near complete nasal obstruction that prevents obtaining a quality signal with the HRP
• History of surgery and / or previous Positive continuous pressure (CPAP) for OSA

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• Instituto de Salud Carlos III: collaborator
• ResMed: collaborator
• Complejo Hospitalario de Caceres: collaborator
• Hospital Universitario de Burgos: collaborator
• Hospital Universitario Marqués de Valdecilla: collaborator
• Hospital de Basurto: collaborator
• Hospital Vall d'Hebron: collaborator
• Fundación Jimenez Diaz de Madrid: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator
• Hospital de Guadalajara: collaborator
• University of Chicago: collaborator

Study Sites (1)

Hospital Universitario Alava

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Related Publications (19)

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  BACKGROUND

• Alonso-Alvarez ML, Cordero-Guevara JA, Teran-Santos J, Gonzalez-Martinez M, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Kheirandish-Gozal L, Gozal D. Obstructive sleep apnea in obese community-dwelling children: the NANOS study. Sleep. 2014 May 1;37(5):943-9. doi: 10.5665/sleep.3666.

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• Gileles-Hillel A, Alonso-Alvarez ML, Kheirandish-Gozal L, Peris E, Cordero-Guevara JA, Teran-Santos J, Martinez MG, Jurado-Luque MJ, Corral-Penafiel J, Duran-Cantolla J, Gozal D. Inflammatory markers and obstructive sleep apnea in obese children: the NANOS study. Mediators Inflamm. 2014;2014:605280. doi: 10.1155/2014/605280. Epub 2014 Jun 1.

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  PMID: 19714380 BACKGROUND

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disease

Interventions

Reproducibility of Results

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. MD,PhD

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: February 28, 2018
• Study Start: May 7, 2015
• Primary Completion: April 30, 2019
• Study Completion: March 30, 2020
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)