Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT03415633
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2016-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}, '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': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': 'baseline', 'description': 'To assess the diagnostic validity of a home respiratory polygraphy (HRP) compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI).'}], 'secondaryOutcomes': [{'measure': 'Therapeutic decision', 'timeFrame': '6 month', 'description': 'The concordance of the diagnosis and treatment decision when using clinical findings and data from standard polysomnography (PSG) or home respiratory polygraphy (HRP).'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'baseline and at 6 month', 'description': 'The Epworth Sleepiness Scale (the sum of 8 items score,0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness.'}, {'measure': 'STOP-BANG Sleep apnea questionnaire', 'timeFrame': 'baseline and at 6 month', 'description': 'Sleep Apnea Questionnaire. High STOP-Bang score indicates a high probability of obstructive sleep apnea.'}, {'measure': 'Berlin questionnaire', 'timeFrame': 'baseline and at 6 month', 'description': 'The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.\n\nHigh Risk:\n\nif there are 2 or more categories where the score is positive.\n\nLow Risk:\n\nif there is only 1 or no categories where the score is positive.'}, {'measure': 'Cost-effectiveness analysis', 'timeFrame': '6 month', 'description': 'Cost-efficacy evaluation'}, {'measure': 'Blood pressure', 'timeFrame': 'baseline and at 6 month', 'description': 'Blood pressure measurements: systolic blood pressure and diastolic blood pressure'}, {'measure': 'Anthropometric variables (Body mass index)', 'timeFrame': 'baseline and at 6 month', 'description': 'Body mass index'}, {'measure': 'Quality of life (EuroQOL test)', 'timeFrame': 'baseline and at 6 month', 'description': 'Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-car, usual activities, pain/discomfort and anxiety/depression), each o wich is defined with three levels of severity, as measured by a Likert scale type (no problems, some problems and many problems or inability to activity).'}]}, 'conditionsModule': {'keywords': ['Home Respiratory Polygraphy', 'Standard Polysomnography', 'Validity', 'Cost-effectiveness'], 'conditions': ['Obstructive Sleep Apnea (OSA)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Durán-Cantolla J, Puertas FJ, Pin G y el Grupo Español de Sueño (GES).Documento de consenso nacional sobre el SAHS. Arch Bronconumol 2005;41(nº4):1-110.'}, {'pmid': '21398016', 'type': 'BACKGROUND', 'citation': 'Lloberes P, Duran-Cantolla J, Martinez-Garcia MA, Marin JM, Ferrer A, Corral J, Masa JF, Parra O, Alonso-Alvarez ML, Teran-Santos J. Diagnosis and treatment of sleep apnea-hypopnea syndrome. Spanish Society of Pulmonology and Thoracic Surgery. Arch Bronconeumol. 2011 Mar;47(3):143-56. doi: 10.1016/j.arbres.2011.01.001. No abstract available. English, Spanish.'}, {'pmid': '19688045', 'type': 'BACKGROUND', 'citation': "Punjabi NM, Caffo BS, Goodwin JL, Gottlieb DJ, Newman AB, O'Connor GT, Rapoport DM, Redline S, Resnick HE, Robbins JA, Shahar E, Unruh ML, Samet JM. Sleep-disordered breathing and mortality: a prospective cohort study. PLoS Med. 2009 Aug;6(8):e1000132. doi: 10.1371/journal.pmed.1000132. Epub 2009 Aug 18."}, {'pmid': '7952834', 'type': 'BACKGROUND', 'citation': 'Duran Cantolla J, Esnaola Sukia S, Rubio Aramendi R, Egea Santaolalla C. [Validity of a portable recording system (MESAM IV) for the diagnosis of sleep apnea syndrome]. Arch Bronconeumol. 1994 Aug-Sep;30(7):331-8. Spanish.'}, {'pmid': '8980975', 'type': 'BACKGROUND', 'citation': 'Esnaola S, Duran J, Infante-Rivard C, Rubio R, Fernandez A. Diagnostic accuracy of a portable recording device (MESAM IV) in suspected obstructive sleep apnoea. Eur Respir J. 1996 Dec;9(12):2597-605. doi: 10.1183/09031936.96.09122597.'}, {'pmid': '9272909', 'type': 'BACKGROUND', 'citation': 'Parra O, Garcia-Esclasans N, Montserrat JM, Garcia Eroles L, Ruiz J, Lopez JA, Guerra JM, Sopena JJ. Should patients with sleep apnoea/hypopnoea syndrome be diagnosed and managed on the basis of home sleep studies? Eur Respir J. 1997 Aug;10(8):1720-4. doi: 10.1183/09031936.97.10081720.'}, {'pmid': '10726178', 'type': 'BACKGROUND', 'citation': 'Jimenez Gomez A, Golpe Gomez R, Carpizo Alfayate R, de la Roza Fernandez C, Fernandez Rozas S, Garcia Perez MM. [The validation of a portable 3-channel recording system (Oxyflow, Edentec) for the diagnosis of the sleep apnea syndrome]. Arch Bronconeumol. 2000 Jan;36(1):7-12. doi: 10.1016/s0300-2896(15)30226-x. Spanish.'}, {'pmid': '12503711', 'type': 'BACKGROUND', 'citation': 'Calleja JM, Esnaola S, Rubio R, Duran J. Comparison of a cardiorespiratory device versus polysomnography for diagnosis of sleep apnoea. Eur Respir J. 2002 Dec;20(6):1505-10. doi: 10.1183/09031936.02.00297402.'}, {'pmid': '14636489', 'type': 'BACKGROUND', 'citation': 'Nunez R, Rey de Castro J, Socarras E, Calleja JM, Rubio R, Aizpuru F, Duran-Cantolla J. [Validation study of a polygraphic screening device (BREAS SC20) in the diagnosis of sleep apnea-hypopnea syndrome]. Arch Bronconeumol. 2003 Dec;39(12):537-43. doi: 10.1016/s0300-2896(03)75451-9. Spanish.'}, {'pmid': '21602541', 'type': 'BACKGROUND', 'citation': 'Masa JF, Corral J, Pereira R, Duran-Cantolla J, Cabello M, Hernandez-Blasco L, Monasterio C, Alonso A, Chiner E, Rubio M, Garcia-Ledesma E, Cacelo L, Carpizo R, Sacristan L, Salord N, Carrera M, Sancho-Chust JN, Embid C, Vazquez-Polo FJ, Negrin MA, Montserrat JM. Effectiveness of home respiratory polygraphy for the diagnosis of sleep apnoea and hypopnoea syndrome. Thorax. 2011 Jul;66(7):567-73. doi: 10.1136/thx.2010.152272. Epub 2011 May 20.'}, {'pmid': '21737584', 'type': 'BACKGROUND', 'citation': 'Masa JF, Corral J, Pereira R, Duran-Cantolla J, Cabello M, Hernandez-Blasco L, Monasterio C, Alonso A, Chiner E, Zamorano J, Aizpuru F, Montserrat JM; Spanish Sleep Network. Therapeutic decision-making for sleep apnea and hypopnea syndrome using home respiratory polygraphy: a large multicentric study. Am J Respir Crit Care Med. 2011 Oct 15;184(8):964-71. doi: 10.1164/rccm.201103-0428OC. Epub 2011 Jul 7.'}, {'pmid': '16171294', 'type': 'BACKGROUND', 'citation': 'Kushida CA, Littner MR, Morgenthaler T, Alessi CA, Bailey D, Coleman J Jr, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Loube DL, Owens J, Pancer JP, Wise M. Practice parameters for the indications for polysomnography and related procedures: an update for 2005. Sleep. 2005 Apr;28(4):499-521. doi: 10.1093/sleep/28.4.499.'}, {'pmid': '8520819', 'type': 'BACKGROUND', 'citation': 'Duran Cantolla J, Amilibia Alonso J, Barbe Illa F, Capote Gil F, Gonzalez-Mangado N, Jimenez Gomez A, Marin Trigo JM, Masa Jimenez JF, Montserrat Canal JM, Teran Santos J. [Availability of technical resources for diagnosis and treatment of sleep obstructive apnea syndrome in state hospitals in Spain]. Arch Bronconeumol. 1995 Nov;31(9):463-9. No abstract available. Spanish.'}, {'pmid': '8417909', 'type': 'BACKGROUND', 'citation': 'Johns MW. Daytime sleepiness, snoring, and obstructive sleep apnea. The Epworth Sleepiness Scale. Chest. 1993 Jan;103(1):30-6. doi: 10.1378/chest.103.1.30.'}, {'pmid': '18431116', 'type': 'BACKGROUND', 'citation': 'Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.'}, {'pmid': '10507956', 'type': 'BACKGROUND', 'citation': 'Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).', 'detailedDescription': 'To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP), performed at home compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA).\n\nMETHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study will include 240 adults, 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) clinical history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) 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 Receiver Operating Characteristic (ROC) curve; 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; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over 18 years to 75 years old, with clinical suspicion of OSA\n* Written informed consent signed\n\nExclusion Criteria:\n\n* Psycho-Physical inability to perform the study at home\n* Presence of insomnia or depressive syndrome\n* Patient with malformation syndromes, Down syndrome and neuromuscular diseases\n* Cardiovascular, cerebrovascular or respiratory disease exacerbated.\n* Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA'}, 'identificationModule': {'nctId': 'NCT03415633', 'acronym': 'APNiA', 'briefTitle': 'Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea', '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', 'orgStudyIdInfo': {'id': '2015-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diagnostic Randomizing', 'description': 'Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)', 'interventionNames': ['Other: Home Respiratory Polygraphy (APNIA)', 'Other: Standard Polysomnography (PSG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic Randomizing', 'description': 'Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)', 'interventionNames': ['Other: Home Respiratory Polygraphy (APNIA)', 'Other: Standard Polysomnography (PSG)']}], 'interventions': [{'name': 'Home Respiratory Polygraphy (APNIA)', 'type': 'OTHER', 'otherNames': ['Validity'], 'description': 'Randomizing to start with home respiratory polygraphy (APNIA)', '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 (APNIA)', 'type': 'OTHER', 'otherNames': ['Effectiveness'], 'description': 'Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)', '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': 'Araba', 'country': 'Spain', 'facility': 'Hospital Universitario Araba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Joaquin Duran-Cantolla', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Araba'}, {'name': 'Eduardo Anitua-Aldecoa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BTI Technology Institute SL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Araba', 'class': 'OTHER'}, 'collaborators': [{'name': 'BTI Biotechnology Institute S.L', 'class': 'UNKNOWN'}, {'name': 'Instituto de Investigación Sanitaria BIO-ARABA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator. MD, PhD', 'investigatorFullName': 'Joaquin Duran-Cantolla, MD', 'investigatorAffiliation': 'Hospital Universitario Araba'}}}}