Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT03449550
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2017-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015203', 'term': 'Reproducibility of Results'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic validity of a Home Respiratory Polygraphy (HRP)', 'timeFrame': 'baseline', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Cost effectiveness analysis', 'timeFrame': 'baseline', 'description': '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).'}, {'measure': 'Validation of the therapeutic decision', 'timeFrame': '6 month', 'description': '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)'}, {'measure': 'Validity of the determination of a protein sequence in urine in OSA', 'timeFrame': 'baseline', 'description': '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'}, {'measure': 'Pediatric Sleep Questionnaire.', 'timeFrame': 'baseline and at six month', 'description': '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.\n\nThe 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'}, {'measure': 'BEARS Sleep screening', 'timeFrame': 'baseline and at six month', 'description': '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'}, {'measure': 'Quality of life (KINDLR)', 'timeFrame': 'baseline and at six month', 'description': '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)'}, {'measure': "Children's sleep habits questionnaire (CSHQ)", 'timeFrame': 'baseline and at six month', 'description': "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."}, {'measure': 'Anthropometric variables', 'timeFrame': 'baseline and at six month', 'description': 'Body mass index'}, {'measure': 'Blood pressure', 'timeFrame': 'baseline and at six month', 'description': 'Blood pressure measurements: systolic blood pressure and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child obstructive sleep apnea', 'Home Respiratory Polygraphy', 'Diagnosis', 'Validity', 'Polysomnography'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '22682520', 'type': 'BACKGROUND', 'citation': 'Luz Alonso-Alvarez M, Canet T, Cubell-Alarco M, Estivill E, Fernandez-Julian E, Gozal D, Jurado-Luque MJ, Lluch-Rosello MA, Martinez-Perez F, Merino-Andreu M, Pin-Arboledas G, Roure N, Sanmarti FX, Sans-Capdevila O, Segarra-Isern F, Tomas-Vila M, Teran-Santos J; Sociedad Espanola de Sueno; Area de Sueno de la Sociedad Espanola de Neumologia y Cirugia Toracica(SEPAR)]. [Consensus document on sleep apnea-hypopnea syndrome in children (full version). Sociedad Espanola de Sueno. El Area de Sueno de la Sociedad Espanola de Neumologia y Cirugia Toracica(SEPAR)]. Arch Bronconeumol. 2011 May;47 Suppl 5:0, 2-18. doi: 10.1016/S0300-2896(11)70026-6. Epub 2011 Jun 22. No abstract available. Spanish.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '24790273', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24991089', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12093948', 'type': 'BACKGROUND', '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. doi: 10.1542/peds.110.1.68.'}, {'pmid': '10733617', 'type': 'BACKGROUND', 'citation': 'Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.'}, {'pmid': '22677350', 'type': 'BACKGROUND', '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.'}, {'pmid': '14702490', 'type': 'BACKGROUND', '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. doi: 10.1542/peds.113.1.e19.'}, {'pmid': '1589307', 'type': 'BACKGROUND', 'citation': 'Marcus CL, Keens TG, Ward SL. Comparison of nap and overnight polysomnography in children. Pediatr Pulmonol. 1992 May;13(1):16-21. doi: 10.1002/ppul.1950130106.'}, {'pmid': '11766164', 'type': 'BACKGROUND', '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. doi: 10.1093/sleep/24.8.937."}, {'pmid': '8606854', 'type': 'BACKGROUND', '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. doi: 10.1002/ppul.1950200407.'}, {'pmid': '16183829', 'type': 'BACKGROUND', '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. doi: 10.1203/01.PDR.0000181372.34213.13. Epub 2005 Sep 23.'}, {'pmid': '18559221', 'type': 'BACKGROUND', 'citation': 'Alonso Alvarez ML, Teran Santos J, Cordero Guevara JA, Navazo Eguia AI, Ordax Carbajo E, Masa Jimenez 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.'}, {'pmid': '23375659', 'type': 'BACKGROUND', '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.'}, {'pmid': '23692173', 'type': 'BACKGROUND', '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.'}, {'pmid': '24109201', 'type': 'BACKGROUND', '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.'}, {'pmid': '19714380', 'type': 'BACKGROUND', '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.'}, {'pmid': '25325484', 'type': 'BACKGROUND', 'citation': 'Masa JF, Duran-Cantolla J, Capote F, Cabello M, Abad J, Garcia-Rio F, Ferrer A, Mayos M, Gonzalez-Mangado N, de la Pena 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, Garcia-Diaz E, Carmona-Bernal C, Sanchez-Armengol A, Fortuna AM, Miralda RM, Troncoso MF, Monica G, Martinez-Martinez M, Cantalejo O, Pierola 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.'}, {'pmid': '19797158', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).\n\nMETHODOLOGY: 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.\n\nANALYSIS: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Written informed consent signed.\n\nExclusion Criteria:\n\n* Place of residence more than 100 km from the hospital\n* Psychophysical incapacity to perform the study at home\n* Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies\n* Children with chronic insomnia and / or depressive syndrome\n* Children with malformative syndromes, Down Syndrome and neuromuscular diseases\n* Complete or near complete nasal obstruction that prevents obtaining a quality signal with the HRP\n* History of surgery and / or previous Positive continuous pressure (CPAP) for OSA'}, 'identificationModule': {'nctId': 'NCT03449550', 'acronym': 'DINISAS', 'briefTitle': 'Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Araba'}, 'officialTitle': 'Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea in Children (DINISAS)', 'orgStudyIdInfo': {'id': 'PI14/01187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diagnostic Randomizing', 'description': 'Randomizing to start with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)', 'interventionNames': ['Other: Home Respiratory Polygraphy (HRP)', 'Other: Standard Polysomnography (PSG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic Randomizing', 'description': 'Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP) or Standard Polysomnography (PSG)', 'interventionNames': ['Other: Home Respiratory Polygraphy (HRP)', 'Other: Standard Polysomnography (PSG)']}], 'interventions': [{'name': 'Home Respiratory Polygraphy (HRP)', 'type': 'OTHER', 'otherNames': ['Validity'], 'description': 'Randomizing to start with home respiratory polygraphy', 'armGroupLabels': ['Diagnostic Randomizing']}, {'name': 'Standard Polysomnography (PSG)', 'type': 'OTHER', 'otherNames': ['Validity'], 'description': 'Randomizing to start with Standard Polysomnography (PSG)', 'armGroupLabels': ['Diagnostic Randomizing']}, {'name': 'Home Respiratory Polygraphy (HRP)', 'type': 'OTHER', 'otherNames': ['Effectiveness'], 'description': 'Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)', 'armGroupLabels': ['Therapeutic Randomizing']}, {'name': 'Standard Polysomnography (PSG)', 'type': 'OTHER', 'otherNames': ['Effectiveness'], 'description': 'Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)', 'armGroupLabels': ['Therapeutic Randomizing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Hospital Universitario Alava', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Araba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'ResMed', 'class': 'INDUSTRY'}, {'name': 'Complejo Hospitalario de Caceres', 'class': 'OTHER'}, {'name': 'Hospital Universitario de Burgos', 'class': 'OTHER'}, {'name': 'Hospital Universitario Marqués de Valdecilla', 'class': 'OTHER'}, {'name': 'Hospital de Basurto', 'class': 'OTHER'}, {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': 'Fundación Jimenez Diaz de Madrid', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, {'name': 'Hospital Clínico Universitario de Valladolid', 'class': 'OTHER'}, {'name': 'Hospital de Guadalajara', 'class': 'UNKNOWN'}, {'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator. MD,PhD', 'investigatorFullName': 'Joaquin Duran-Cantolla, MD', 'investigatorAffiliation': 'Hospital Universitario Araba'}}}}