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

NCT03415633 | Completed

• 1 other identifier: 2015-026
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Home Respiratory Polygraphy; Standard Polysomnography; Validity; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Therapeutic decision

  6 month

• Epworth Sleepiness Scale

  baseline and at 6 month

• STOP-BANG Sleep apnea questionnaire

  baseline and at 6 month

• Berlin questionnaire

  baseline and at 6 month

• Cost-effectiveness analysis

  6 month

Study Arms (2)

Diagnostic Randomizing

ACTIVE COMPARATOR

Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)

Other: Home Respiratory Polygraphy (APNIA); Other: Standard Polysomnography (PSG)

Therapeutic Randomizing

ACTIVE COMPARATOR

Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)

Other: Home Respiratory Polygraphy (APNIA); Other: Standard Polysomnography (PSG)

Interventions

Home Respiratory Polygraphy (APNIA) OTHER

Randomizing to start with home respiratory polygraphy (APNIA)

Also known as: Validity

Diagnostic Randomizing

Standard Polysomnography (PSG) OTHER

Randomizing to start with Standard Polysomnography (PSG)

Also known as: Validity

Diagnostic Randomizing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• BTI Biotechnology Institute S.L: collaborator
• Instituto de Investigación Sanitaria BIO-ARABA: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Related 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.

  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.

  PMID: 21398016 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.

  PMID: 19688045 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.

  PMID: 7952834 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.

  PMID: 8980975 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.

  PMID: 9272909 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.

  PMID: 10726178 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.

  PMID: 12503711 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.

  PMID: 14636489 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.

  PMID: 21602541 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.

  PMID: 21737584 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.

  PMID: 16171294 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.

  PMID: 8520819 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.

  PMID: 8417909 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.

  PMID: 18431116 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.

  PMID: 10507956 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.

  PMID: 19714380 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Reproducibility of Results

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Evaluation Studies as Topic; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Joaquin Duran-Cantolla

  Hospital Universitario Araba

  STUDY DIRECTOR

• Eduardo Anitua-Aldecoa

  BTI Technology Institute SL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. MD, PhD

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: January 30, 2018
• Study Start: September 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)