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

Obstructive Sleep Apnea Clinical Trial

— DINISAS  

Official title:

Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03449550
• Other study ID #: PI14/01187
• Status: Completed
• Phase: N/A
• Start date: May 7, 2015
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2021
• Source: Hospital Universitario Araba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

AIMS: 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).

METHODOLOGY: DESIGN: Randomized, prospective, multicenter, double blind and crossover trial. The study will include 320 children, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinic history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c) Chervin questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Quantitative unbiased proteinic urine analysis and g) Cost-effectiveness variables.

ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the ROC curves; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home, 3) All data will be analyzed independently by participating hospitals according the Cohen Kappa method, 4) A diagnosis paradigm based on proteinic defined variables and 5) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 30, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Home Respiratory Polygraphy (HRP)
Randomizing to start with home respiratory polygraphy
• Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
• Home Respiratory Polygraphy (HRP)
Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
• Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Locations

Country	Name	City	State
Spain	Hospital Universitario Alava	Vitoria-gasteiz	Alava

Sponsors (14)

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

Country where clinical trial is conducted

Spain, 

References & Publications (19)

Alonso Alvarez ML, Terán Santos J, Cordero Guevara JA, Navazo Egüia AI, Ordax Carbajo E, Masa Jiménez JF, Pelayo R. [Reliability of respiratory polygraphy for the diagnosis of sleep apnea-hypopnea syndrome in children]. Arch Bronconeumol. 2008 Jun;44(6):318-23. Spanish. — View Citation

Alonso-Álvarez ML, Cordero-Guevara JA, Terán-Santos J, Gonzalez-Martinez M, Jurado-Luque MJ, Corral-Peñafiel 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. — View Citation

Brockmann PE, Schaefer C, Poets A, Poets CF, Urschitz MS. Diagnosis of obstructive sleep apnea in children: a systematic review. Sleep Med Rev. 2013 Oct;17(5):331-40. doi: 10.1016/j.smrv.2012.08.004. Epub 2013 Jan 30. Review. — View Citation

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Gileles-Hillel A, Alonso-Álvarez ML, Kheirandish-Gozal L, Peris E, Cordero-Guevara JA, Terán-Santos J, Martinez MG, Jurado-Luque MJ, Corral-Peñafiel 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. — View Citation

Goodwin JL, Enright PL, Kaemingk KL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2001 Dec 15;24(8):937-44. — View Citation

Gozal D, Jortani S, Snow AB, Kheirandish-Gozal L, Bhattacharjee R, Kim J, Capdevila OS. Two-dimensional differential in-gel electrophoresis proteomic approaches reveal urine candidate biomarkers in pediatric obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1253-61. doi: 10.1164/rccm.200905-0765OC. Epub 2009 Sep 24. — View Citation

Jacob SV, Morielli A, Mograss MA, Ducharme FM, Schloss MD, Brouillette RT. Home testing for pediatric obstructive sleep apnea syndrome secondary to adenotonsillar hypertrophy. Pediatr Pulmonol. 1995 Oct;20(4):241-52. — View Citation

Luz Alonso-Álvarez M, Canet T, Cubell-Alarco M, Estivill E, Fernández-Julián E, Gozal D, Jurado-Luque MJ, Lluch-Roselló MA, Martínez-Pérez F, Merino-Andreu M, Pin-Arboledas G, Roure N, Sanmartí FX, Sans-Capdevila O, Segarra-Isern F, Tomás-Vila M, Terán-Santos J; Sociedad Española de Sueño; Área de Sueño de la Sociedad Española de Neumología y Cirugía Torácica(SEPAR)]. [Consensus document on sleep apnea-hypopnea syndrome in children (full version). Sociedad Española de Sueño. El Área de Sueño de la Sociedad Española de Neumología y Cirugía Torácica(SEPAR)]. Arch Bronconeumol. 2011 May;47 Suppl 5:0, 2-18. doi: 10.1016/S0300-2896(11)70026-6. Epub 2011 Jun 22. Spanish. — View Citation

Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J et al. American Academy of Pediatrics Statement. Clinical practice guideline: diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics109:704-23, 2002.

Marcus CL, Keens TG, Ward SL. Comparison of nap and overnight polysomnography in children. Pediatr Pulmonol. 1992 May;13(1):16-21. — View Citation

Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21. — View Citation

Masa JF, Duran-Cantolla J, Capote F, Cabello M, Abad J, Garcia-Rio F, Ferrer A, Mayos M, Gonzalez-Mangado N, de la Peña M, Aizpuru F, Barbe F, Montserrat JM; Spanish Sleep Network, Larrateguy LD, de Castro JR, Garcia-Ledesma E, Utrabo I, Corral J, Martinez-Null C, Egea C, Cancelo L, García-Díaz E, Carmona-Bernal C, Sánchez-Armengol A, Fortuna AM, Miralda RM, Troncoso MF, Monica G, Martinez-Martinez M, Cantalejo O, Piérola J, Vigil L, Embid C, Del Mar Centelles M, Prieto TR, Rojo B, Vanesa L. Effectiveness of home single-channel nasal pressure for sleep apnea diagnosis. Sleep. 2014 Dec 1;37(12):1953-61. doi: 10.5665/sleep.4248. — View Citation

Moss D, Urschitz MS, von Bodman A, Eitner S, Noehren A, Urschitz-Duprat PM, Schlaud M, Poets CF. Reference values for nocturnal home polysomnography in primary schoolchildren. Pediatr Res. 2005 Nov;58(5):958-65. Epub 2005 Sep 23. — View Citation

Nixon GM, Kermack AS, Davis GM, Manoukian JJ, Brown KA, Brouillette RT. Planning adenotonsillectomy in children with obstructive sleep apnea: the role of overnight oximetry. Pediatrics. 2004 Jan;113(1 Pt 1):e19-25. — View Citation

Ragette R, Wang Y, Weinreich G, Teschler H. Diagnostic performance of single airflow channel recording (ApneaLink) in home diagnosis of sleep apnea. Sleep Breath. 2010 Jun;14(2):109-14. doi: 10.1007/s11325-009-0290-2. Epub 2009 Aug 28. — View Citation

Reuveni H, Simon T, Tal A, Elhayany A, Tarasiuk A. Health care services utilization in children with obstructive sleep apnea syndrome. Pediatrics. 2002 Jul;110(1 Pt 1):68-72. — View Citation

Spruyt K, Gozal D. Screening of pediatric sleep-disordered breathing: a proposed unbiased discriminative set of questions using clinical severity scales. Chest. 2012 Dec;142(6):1508-1515. doi: 10.1378/chest.11-3164. — View Citation

Tan HL, Gozal D, Kheirandish-Gozal L. Obstructive sleep apnea in children: a critical update. Nat Sci Sleep. 2013 Sep 25;5:109-23. doi: 10.2147/NSS.S51907. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cost effectiveness analysis	Cost-efficacy evaluation: the analysis will be made in both arms based on intention to treat. Only direct costs will be analyzed: the cost of the use of polysomnography and home respiratory polygraphy (Staff and consumable material).	baseline
Secondary	Validation of the therapeutic decision	Analyze the concordance in the therapeutic decision using clinical findings and the results of Apnea-Hypopnea Index (AHI) from standard polysomnography (PSG) compared with data from home respiratory polygraphy (HRP)	6 month
Secondary	Validity of the determination of a protein sequence in urine in OSA	To analyze the validity of the determination of a protein sequence in urine, alone or in combination, to establish the diagnosis of OSA and to evaluate its modification over time after the treatment of OSA	baseline
Secondary	Pediatric Sleep Questionnaire.	Pediatric Sleep Questionnaire designed to screen for sleep problems in children.The scale consists of 22 parent-reported items examining snoring and breathing problems, daytime sleepiness, inattention, hyperactivity, and other signs and symptoms of apnea including obesity and nocturnal enuresis.; The result is a number, a proportion that ranges from 0.0 to 1.0. Scores >0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorder	baseline and at six month
Secondary	BEARS Sleep screening	BEARS Sleep screening is divided into five major sleep domains (B=Bedtime Issues, E=Excessive Daytime Sleepiness, A=Night Awakenings, R=Regularity and Duration of Sleep, S=Snoring), providing a comprehensive screen for the major sleep disorders affecting children in the 2- to 18-year old range	baseline and at six month
Secondary	Quality of life (KINDLR)	The KINDLR is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3 years and older. Consists of 24 Likert-scaled items associated with six dimensions: physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school). The response categories cover 3 levels (1=never, 2=sometimes, 3=very often)	baseline and at six month
Secondary	Children's sleep habits questionnaire (CSHQ)	Parent-report sleep screening instrument designed for school-aged children.The instrument evaluates the child's sleep based on behavior within eight different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness.	baseline and at six month
Secondary	Anthropometric variables	Body mass index	baseline and at six month
Secondary	Blood pressure	Blood pressure measurements: systolic blood pressure and diastolic blood pressure	baseline and at six month