Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
NCT ID: NCT03415633
Last Updated: 2018-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
251 participants
INTERVENTIONAL
2015-09-30
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnosis of Patients With Low or Intermediate Suspicion of SAHS or With Comorbidity: Standard Laboratory Polysomnography Compared With Three Nights of Home Respiratory Polygraphy.
NCT01820156
Cost-effectiveness of Home Respiratory Polygraphy
NCT01752556
Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home
NCT00614952
Home Nasal Pressure for Sleep Apnea Management in Primary Case
NCT02141165
Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
NCT01001858
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
METHODOLOGY: 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.
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 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diagnostic Randomizing
Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
Home Respiratory Polygraphy (APNIA)
Randomizing to start with home respiratory polygraphy (APNIA)
Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Therapeutic Randomizing
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
Home Respiratory Polygraphy (APNIA)
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Home Respiratory Polygraphy (APNIA)
Randomizing to start with home respiratory polygraphy (APNIA)
Standard Polysomnography (PSG)
Randomizing to start with Standard Polysomnography (PSG)
Home Respiratory Polygraphy (APNIA)
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent signed
Exclusion Criteria
* Presence of insomnia or depressive syndrome
* Patient with malformation syndromes, Down syndrome and neuromuscular diseases
* Cardiovascular, cerebrovascular or respiratory disease exacerbated.
* Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BTI Biotechnology Institute S.L
UNKNOWN
Instituto de Investigación Sanitaria BIO-ARABA
UNKNOWN
Hospital Universitario Araba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joaquin Duran-Cantolla, MD
Principal Investigator. MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joaquin Duran-Cantolla
Role: STUDY_DIRECTOR
Hospital Universitario Araba
Eduardo Anitua-Aldecoa
Role: PRINCIPAL_INVESTIGATOR
BTI Technology Institute SL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-026
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.