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Obstructive Sleep Apnea (OSA)APNiANCT03415633

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

A study testing Home Respiratory Polygraphy (APNIA) and Standard Polysomnography (PSG) in people with Obstructive Sleep Apnea (OSA), run by Hospital Universitario Araba at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
Home Respiratory Polygraphy (APNIA) and Standard Polysomnography (PSG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
1 siteSpain
Study dates
Sep 2015to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Araba

    Vitoria-Gasteiz, Araba, 01009

Other trials in Spain

About this study

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

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

Read the detailed 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.

Being tested
Home Respiratory Polygraphy (APNIA), Standard Polysomnography (PSG)
Keywords
Home Respiratory Polygraphy, Standard Polysomnography, Validity, Cost-effectiveness
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home Respiratory Polygraphy (APNIA)Other

    Also called Validity

    Randomizing to start with home respiratory polygraphy (APNIA)

  • Standard Polysomnography (PSG)Other

    Also called Validity

    Randomizing to start with Standard Polysomnography (PSG)

  • Home Respiratory Polygraphy (APNIA)Other

    Also called Effectiveness

    Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)

  • Standard Polysomnography (PSG)Other

    Also called Effectiveness

    Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Study groups in NCT03415633
Study groupRoleWhat they receive
Diagnostic RandomizingActive comparatorRandomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
Receives: Other: Home Respiratory Polygraphy (APNIA); Other: Standard Polysomnography (PSG)
Therapeutic RandomizingActive comparatorRandomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG)
Receives: Other: Home Respiratory Polygraphy (APNIA); Other: Standard Polysomnography (PSG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline

Secondary outcomes (8)

  1. 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).

    Measured: 6 month

  2. 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.

    Measured: baseline and at 6 month

  3. STOP-BANG Sleep apnea questionnaire

    Sleep Apnea Questionnaire. High STOP-Bang score indicates a high probability of obstructive sleep apnea.

    Measured: baseline and at 6 month

  4. 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.

    Measured: baseline and at 6 month

  5. Cost-effectiveness analysis

    Cost-efficacy evaluation

    Measured: 6 month

  6. Blood pressure

    Blood pressure measurements: systolic blood pressure and diastolic blood pressure

    Measured: baseline and at 6 month

  7. Anthropometric variables (Body mass index)

    Body mass index

    Measured: baseline and at 6 month

  8. 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).

    Measured: baseline and at 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study startSep 2015
  3. Primary completionJun 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415633
Sponsor's protocol ID
2015-026
Acronym
APNiA
Status last verified
Sep 2018
First submitted
30 Sep 2016
Last updated
6 Sep 2018
Results posted
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21398016

  • 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.

    PubMed 19688045

  • 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.

    PubMed 7952834

  • 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.

    PubMed 8980975

  • 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.

    PubMed 9272909

  • 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.

    PubMed 10726178

  • 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.

    PubMed 12503711

  • 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.

    PubMed 14636489

  • 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.

    PubMed 21602541

  • 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.

    PubMed 21737584

  • 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.

    PubMed 16171294

  • 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.

    PubMed 8520819

  • 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.

    PubMed 8417909

  • 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.

    PubMed 18431116

Questions about this trial

What is this clinical trial studying?

A study testing Home Respiratory Polygraphy (APNIA) and Standard Polysomnography (PSG) in people with Obstructive Sleep Apnea (OSA), run by Hospital Universitario Araba at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-Hypopnea Index (AHI) (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03415633, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.

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