Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) Clinical Trial

— APNiA  

Official title:

Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415633
• Other study ID #: 2015-026
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• 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 APNiA device, a home respiratory polygraphy (HRP).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women over 18 years to 75 years old, with clinical suspicion of OSA

• Written informed consent signed

Exclusion Criteria:

• Psycho-Physical inability to perform the study at home

• 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Spain	Hospital Universitario Araba	Gasteiz / Vitoria	Araba

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Araba	BTI Biotechnology Institute S.L, Instituto de Investigación Sanitaria BIO-ARABA

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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.

Calleja JM, Esnaola S, Rubio R, Durán J. Comparison of a cardiorespiratory device versus polysomnography for diagnosis of sleep apnoea. Eur Respir J. 2002 Dec;20(6):1505-10. — View 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. — View Citation

Durán Cantolla J, Amilibia Alonso J, Barbé Illá F, Capote Gil F, González-Mangado N, Jiménez Gómez A, Marín Trigo JM, Masa Jiménez JF, Montserrat Canal JM, Terán 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. Spanish. — View Citation

Durán 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. — View Citation

Esnaola S, Durán J, Infante-Rivard C, Rubio R, Fernández A. Diagnostic accuracy of a portable recording device (MESAM IV) in suspected obstructive sleep apnoea. Eur Respir J. 1996 Dec;9(12):2597-605. — View Citation

Jiménez Gómez A, Golpe Gómez R, Carpizo Alfayate R, de la Roza Fernández C, Fernández Rozas S, García Pérez 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. Spanish. — View Citation

Johns MW. Daytime sleepiness, snoring, and obstructive sleep apnea. The Epworth Sleepiness Scale. Chest. 1993 Jan;103(1):30-6. — View 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. Review. — View Citation

Lloberes P, Durán-Cantolla J, Martínez-García MÁ, Marín JM, Ferrer A, Corral J, Masa JF, Parra O, Alonso-Álvarez ML, Terán-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. English, Spanish. Erratum in: Arch Bronconeumol. 2011 Jul;47(7):378. — View Citation

Masa JF, Corral J, Pereira R, Duran-Cantolla J, Cabello M, Hernández-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, Vázquez-Polo FJ, Negrín 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. — View Citation

Masa JF, Corral J, Pereira R, Duran-Cantolla J, Cabello M, Hernández-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. Erratum in: Am J Respir Crit Care Med. 2012 Jan 15;185(2):233. — View 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. — View Citation

Núñez R, Rey de Castro J, Socarrás E, Calleja JM, Rubio R, Aizpuru F, Durán-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. Spanish. — View Citation

Parra O, García-Esclasans N, Montserrat JM, García Eroles L, Ruíz J, López JA, Guerra JM, Sopeña 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. — View 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. — 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

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Epworth Sleepiness Scale	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
Secondary	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
Secondary	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
Secondary	Cost-effectiveness analysis	Cost-efficacy evaluation	6 month
Secondary	Blood pressure	Blood pressure measurements: systolic blood pressure and diastolic blood pressure	baseline and at 6 month
Secondary	Anthropometric variables (Body mass index)	Body mass index	baseline and at 6 month
Secondary	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