- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01405976
Alternative of Treatment in Obesity Hypoventilation Syndrome
22. september 2017 opdateret af: Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables.
As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events.
Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia.
Methods:prospective, randomized controlled trial.
Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, >=30 and < 30, using conventional polysomnography.
The AHI >=30 group will be randomized to CPAP, NIV or life style modification treatments.
The AHI <=30 groups will be randomized to NIV or life style modification treatments.
Treatment efficacy at the medium- and long-term will be analyzed by comparing groups.
The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study.
The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The AHI >=30 group will be analyzed to CPAP, NIV or life style modification treatments for two mouths.Once an evaluation is done during this period, the life style modification treatment will be randomized with the NIV/CPAP treatment for a continuation of three years.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
440
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cáceres, Spanien, 10003
- Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 80 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age between 15 and 80 years old.
- Absence of moderate or severe chronic obstructive pulmonary disease (COPD).
- Absence of neuromuscular, chest wall or metabolic disease which cause daytime hypercapnia.
- Absence of narcolepsy or restless legs syndrome
- Exceed correctly treatment of at least 30 minutes with CPAP/NIV at wakefulness.
Exclusion Criteria:
- Psychophysical incapacity to answer questionnaires.
- Patients who are not able to be evaluated by means of quality of life questionnaires for suffering restrictive chronic disease previously diagnosed (neoplasy, chronic pain of any origin, renal failure, severe chronic obstructive pulmonary disease and any other restrictive chronic disease).
- Subjects with important chronic nasal obstruction that prevents from using CPAP/NIV.
- Informed consent not obtained.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 1
NIV for severe OSA group
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life style modification, noninvasive ventilation, CPAP
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Aktiv komparator: 2
CPAP for severe OSA group
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life style modification, noninvasive ventilation, CPAP
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Aktiv komparator: 3
Life stile modification for severe OSA group
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life style modification, noninvasive ventilation, CPAP
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Aktiv komparator: 4
NIV for non-severe OSA group
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life style modification, noninvasive ventilation, CPAP
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Aktiv komparator: 5
Life stile modification for non-severe OSA group
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life style modification, noninvasive ventilation, CPAP
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Days of hospitalization
Tidsramme: at least three years
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Days of hospitalization
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at least three years
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PaCO2
Tidsramme: at the end of first two months
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PaCO2
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at the end of first two months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Dropouts for Medical reasons and mortality
Tidsramme: at least three years
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Number of Dropouts for Medical reasons and mortality
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at least three years
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quality of life
Tidsramme: two months and three years
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quality of life
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two months and three years
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respiratory function
Tidsramme: two months and three years
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respiratory function
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two months and three years
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polysomnographic parameters
Tidsramme: two months
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polysomnographic parameters
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two months
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molecular inflammation and endothelial dysfunction
Tidsramme: two months and three years
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molecular inflammation and endothelial dysfunction
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two months and three years
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echocardiographic parameters
Tidsramme: two months and three years
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echocardiographic parameters
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two months and three years
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Blood pressure and new cardiovascular events
Tidsramme: three years
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Blood pressure and new cardiovascular events
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three years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Juan F Masa, MD, Hospital San Pedro de Alcántara. Cáceres. Spain
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Masa JF, Benitez ID, Javaheri S, Mogollon MV, Sanchez-Quiroga MA, de Terreros FJG, Corral J, Gallego R, Romero A, Caballero-Eraso C, Ordax-Carbajo E, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Barbe F, Mokhlesi B; Spanish Sleep Network. Risk factors associated with pulmonary hypertension in obesity hypoventilation syndrome. J Clin Sleep Med. 2022 Apr 1;18(4):983-992. doi: 10.5664/jcsm.9760.
- Masa JF, Benitez I, Sanchez-Quiroga MA, Gomez de Terreros FJ, Corral J, Romero A, Caballero-Eraso C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Mokhlesi B; Spanish Sleep Network. Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial. Chest. 2020 Sep;158(3):1176-1186. doi: 10.1016/j.chest.2020.03.068. Epub 2020 Apr 25.
- Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros Caro FJ, Sanchez-Quiroga MA, Romero A, Caballero C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral-Penafiel J; Spanish Sleep Network. Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea. Thorax. 2020 Jun;75(6):459-467. doi: 10.1136/thoraxjnl-2019-213622. Epub 2020 Mar 26.
- Masa JF, Mokhlesi B, Benitez I, Mogollon MV, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Alonso-Alvarez ML, Ordax-Carbajo E, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Echocardiographic Changes with Positive Airway Pressure Therapy in Obesity Hypoventilation Syndrome. Long-Term Pickwick Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2020 Mar 1;201(5):586-597. doi: 10.1164/rccm.201906-1122OC.
- Masa JF, Mokhlesi B, Benitez I, Gomez de Terreros FJ, Sanchez-Quiroga MA, Romero A, Caballero-Eraso C, Teran-Santos J, Alonso-Alvarez ML, Troncoso MF, Gonzalez M, Lopez-Martin S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Barca J, Vazquez-Polo FJ, Negrin MA, Martel-Escobar M, Barbe F, Corral J; Spanish Sleep Network. Long-term clinical effectiveness of continuous positive airway pressure therapy versus non-invasive ventilation therapy in patients with obesity hypoventilation syndrome: a multicentre, open-label, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1721-1732. doi: 10.1016/S0140-6736(18)32978-7. Epub 2019 Mar 29.
- Corral J, Mogollon MV, Sanchez-Quiroga MA, Gomez de Terreros J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, de Lucas P, Marin JM, Romero O, Diaz-Cambriles T, Chiner E, Egea C, Lang RM, Mokhlesi B, Masa JF; Spanish Sleep Network. Echocardiographic changes with non-invasive ventilation and CPAP in obesity hypoventilation syndrome. Thorax. 2018 Apr;73(4):361-368. doi: 10.1136/thoraxjnl-2017-210642. Epub 2017 Nov 16.
- Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martinez S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network. The Effect of Supplemental Oxygen in Obesity Hypoventilation Syndrome. J Clin Sleep Med. 2016 Oct 15;12(10):1379-1388. doi: 10.5664/jcsm.6194.
- Masa JF, Corral J, Caballero C, Barrot E, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Egea C, Miranda E, Mokhlesi B; Spanish Sleep Network; Garcia-Ledesma E, Sanchez-Quiroga MA, Ordax E, Gonzalez-Mangado N, Troncoso MF, Martinez-Martinez MA, Cantalejo O, Ojeda E, Carrizo SJ, Gallego B, Pallero M, Ramon MA, Diaz-de-Atauri J, Munoz-Mendez J, Senent C, Sancho-Chust JN, Ribas-Solis FJ, Romero A, Benitez JM, Sanchez-Gomez J, Golpe R, Santiago-Recuerda A, Gomez S, Bengoa M. Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea. Thorax. 2016 Oct;71(10):899-906. doi: 10.1136/thoraxjnl-2016-208501. Epub 2016 Jul 12.
- Masa JF, Corral J, Romero A, Caballero C, Teran-Santos J, Alonso-Alvarez ML, Gomez-Garcia T, Gonzalez M, Lopez-Martin S, De Lucas P, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Merchan M, Egea C, Obeso A, Mokhlesi B; Spanish Sleep Network( *). Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome. Chest. 2016 Jul;150(1):68-79. doi: 10.1016/j.chest.2016.02.647. Epub 2016 Feb 27.
- Masa JF, Corral J, Alonso ML, Ordax E, Troncoso MF, Gonzalez M, Lopez-Martinez S, Marin JM, Marti S, Diaz-Cambriles T, Chiner E, Aizpuru F, Egea C; Spanish Sleep Network. Efficacy of Different Treatment Alternatives for Obesity Hypoventilation Syndrome. Pickwick Study. Am J Respir Crit Care Med. 2015 Jul 1;192(1):86-95. doi: 10.1164/rccm.201410-1900OC.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2009
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
3. juli 2008
Først indsendt, der opfyldte QC-kriterier
28. juli 2011
Først opslået (Skøn)
29. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. september 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Apnø
- Respirationsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvågningsforstyrrelser
- Sygdom
- Overernæring
- Ernæringsforstyrrelser
- Overvægtig
- Kropsvægt
- Tegn og symptomer, luftveje
- Søvnapnø syndromer
- Respiratorisk insufficiens
- Søvnapnø, obstruktiv
- Syndrom
- Fedme
- Hypoventilation
- Fedme Hypoventilationssyndrom
Andre undersøgelses-id-numre
- PI080346
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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