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| Name | Class |
|---|---|
| BTI Biotechnology Institute S.L | UNKNOWN |
| Instituto de Investigación Sanitaria BIO-ARABA | UNKNOWN |
To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Randomizing | Active Comparator | Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG) |
|
| Therapeutic Randomizing | Active Comparator | Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Respiratory Polygraphy (APNIA) | Other | Randomizing to start with home respiratory polygraphy (APNIA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | 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). | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic decision | The concordance of the diagnosis and treatment decision when using clinical findings and data from standard polysomnography (PSG) or home respiratory polygraphy (HRP). | 6 month |
| Epworth Sleepiness Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Duran-Cantolla | Hospital Universitario Araba | Study Director |
| Eduardo Anitua-Aldecoa | BTI Technology Institute SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Vitoria-Gasteiz | Araba | 01009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 21398016 | Background | 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. | |
| 19688045 |
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| Standard Polysomnography (PSG) | Other | Randomizing to start with Standard Polysomnography (PSG) |
|
|
| Home Respiratory Polygraphy (APNIA) | Other | Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) |
|
|
| Standard Polysomnography (PSG) | Other | Randomizing for therapeutic decision taken with Standard Polysomnography (PSG) |
|
|
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.
| baseline and at 6 month |
| STOP-BANG Sleep apnea questionnaire | Sleep Apnea Questionnaire. High STOP-Bang score indicates a high probability of obstructive sleep apnea. | baseline and at 6 month |
| Berlin questionnaire | 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. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. | baseline and at 6 month |
| Cost-effectiveness analysis | Cost-efficacy evaluation | 6 month |
| Blood pressure | Blood pressure measurements: systolic blood pressure and diastolic blood pressure | baseline and at 6 month |
| Anthropometric variables (Body mass index) | Body mass index | baseline and at 6 month |
| Quality of life (EuroQOL test) | 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). | baseline and at 6 month |
| Background |
| 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. |
| 7952834 | Background | 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. |
| 8980975 | Background | 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. |
| 9272909 | Background | 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. |
| 10726178 | Background | 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. |
| 12503711 | Background | 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. |
| 14636489 | Background | 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. |
| 21602541 | Background | 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. |
| 21737584 | Background | 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. |
| 16171294 | Background | 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. |
| 8520819 | Background | 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. |
| 8417909 | Background | 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. |
| 18431116 | Background | 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. |
| 10507956 | Background | 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. |
| 19714380 | Background | 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. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015203 | Reproducibility of Results |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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