- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02209220
Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery (APAP-CPAP)
1. august 2019 opdateret af: Frédéric Sériès, Laval University
Impact of Automatic Positive Airway Pressure on Treatment Compliance in Obstructive Sleep Apnea Patients Awaiting Bariatric Surgery
Obstructive sleep apnea (OSA) is a syndrome characterized by intermittent dynamic obstruction of the upper airways that causes a fall in oxygen saturation, reflex sympathetic activation and sleep micro-arousals.
In surgical patients, OSA is a well-known risk factor for perioperative complications.
At Institut Universitaire de cardiologie et de Pneumologie de Quebec (IUCPQ), the investigators perform more than 450 bariatric surgeries per year.
Consequently, the identification and management of OSA in this high-risk surgical population is an essential part of practice.
Actual guidelines recommend that treatment for OSA be initiated before the surgical procedure.
Presently, the first line treatment for OSA is continuous positive airway pressure (CPAP) therapy delivering a fixed pressure continuously to maintain the patency of the upper airways.
However the compliance to this therapy is poor.
An available alternative is automatic positive airway pressure (APAP) which delivers a variable amount of pressure to prevent reduction in airflow that accompanies upper airway obstruction.
The APAP delivers the lowest pressure needed to prevent upper airways collapse.
APAP significantly reduces the mean level of pressure delivered in comparison to conventional treatment.
Theoretically, it seems logical that applying the lowest pressure necessary would allow a better device-patient synchrony and therefore improve patient's comfort.Recent trials comparing APAP and CPAP have shown that APAP is non-inferior to CPAP in controlling obstructive events.
APAP would be a valuable alternative if it was not for its excess cost.
However, APAP improves compliance to treatment in two types of population: poor compliant subjects and those needing high pressure levels.
The investigators know that compliance to positive pressure is poor in patients without excessive daytime sleepiness, which represents the majority of patient waiting bariatric surgery.
Moreover, in patients needing levels of pressure ≥ 10 water cm (cmH20), APAP improves treatment compliance, minimises side effects and improves quality of life.
The review of 180 files of OSA patients treated by CPAP who had bariatric surgery in our center in 2012 demonstrated that the majority of patients needed high level pressure.
These values suggest that APAP could improve treatment compliance in apneic patients waiting for bariatric surgery because they are usually poorly symptomatic and they generally require high positive pressure level.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Quebec
-
Quebec City, Quebec, Canada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Obese patients with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with additional risk factors for cardiovascular disease and eligible for bariatric surgery;
- Laparoscopic bariatric surgery planned in 2-6 months. Procedures include biliopancreatic diversion with duodenal switch and sleeve gastrectomy;
- Recent diagnosis of obstructive sleep apnea made by a sleep study. The sleep study must be a overnight pulse oximetry showing a 3% desaturation index ≥ 25/hour or a polysomnography with a apnea + hypopnea index (AHI) ≥ 25/hour* ;
- No previous use of positive airway pressure device;
- ≥18 year old.
Exclusion Criteria:
- Severe comorbidities (respiratory, cardiac, neurologic or metabolic unstable disease);
- Central sleep apnea;
- Obesity hypoventilation syndrome;
- Planned bariatric surgery by laparotomy;
- Contraindications to positive airway pressure therapy: pneumothorax within the preceding 6 months, cerebrospinal fluid leak, cranial surgery or trauma within the last year.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Automatic positive airway pressure
Automatic positive airway pressure treatment of obstructive sleep apnea
|
Andre navne:
|
|
Aktiv komparator: Continuous positive airway pressure
Continuous positive airway pressure for the treatment of obstructive sleep apnea
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compliance of APAP and CPAP
Tidsramme: at time of surgery
|
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
|
at time of surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean pressure level with APAP and CPAP
Tidsramme: at time of surgery
|
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
|
at time of surgery
|
|
Mean pressure level with APAP and CPAP
Tidsramme: 1 month
|
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
|
1 month
|
|
Residual apnea + hypopnea index
Tidsramme: at time of surgery
|
Number of residual respiratory events recorded by the positive pressure device during the treatment period
|
at time of surgery
|
|
Residual apnea + hypopnea index
Tidsramme: 1 month
|
Number of residual respiratory events recorded by the positive pressure device during the treatment period
|
1 month
|
|
epworth sleepiness score
Tidsramme: at time of surgery
|
Somnolence measured by Epworth Sleepiness Scale;
|
at time of surgery
|
|
quality of life score with APAP and CPAP
Tidsramme: at time of surgery
|
Quality of life measured by Questionnaire sur la Qualité de vie du Québec
|
at time of surgery
|
|
Positive pressure therapy adverse events
Tidsramme: at time of surgery
|
Positive airway pressure adverse effects measured by a visual analogic scale.
|
at time of surgery
|
|
Compliance of APAP and CPAP
Tidsramme: 1 month
|
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
|
1 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Frédéric Séries, MD, Laval University
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
- Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Kaw R, Chung F, Pasupuleti V, Mehta J, Gay PC, Hernandez AV. Meta-analysis of the association between obstructive sleep apnoea and postoperative outcome. Br J Anaesth. 2012 Dec;109(6):897-906. doi: 10.1093/bja/aes308. Epub 2012 Sep 6.
- Kuna ST, Reboussin DM, Borradaile KE, Sanders MH, Millman RP, Zammit G, Newman AB, Wadden TA, Jakicic JM, Wing RR, Pi-Sunyer FX, Foster GD; Sleep AHEAD Research Group of the Look AHEAD Research Group. Long-term effect of weight loss on obstructive sleep apnea severity in obese patients with type 2 diabetes. Sleep. 2013 May 1;36(5):641-649A. doi: 10.5665/sleep.2618.
- Smith I, Lasserson TJ. Pressure modification for improving usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003531. doi: 10.1002/14651858.CD003531.pub3.
- Parish JM, Miller BW, Hentz JG. Autotitration positive airway pressure therapy in patients with obstructive sleep apnea who are intolerant of fixed continuous positive airway pressure. Sleep Breath. 2008 Aug;12(3):235-41. doi: 10.1007/s11325-007-0158-2. Epub 2007 Nov 28.
- Wolkove N, Baltzan M, Kamel H, Dabrusin R, Palayew M. Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea. Can Respir J. 2008 Oct;15(7):365-9. doi: 10.1155/2008/534372.
- Massie CA, McArdle N, Hart RW, Schmidt-Nowara WW, Lankford A, Hudgel DW, Gordon N, Douglas NJ. Comparison between automatic and fixed positive airway pressure therapy in the home. Am J Respir Crit Care Med. 2003 Jan 1;167(1):20-3. doi: 10.1164/rccm.200201-022OC. Epub 2002 Oct 4.
- Lacasse Y, Bureau MP, Series F. A new standardised and self-administered quality of life questionnaire specific to obstructive sleep apnoea. Thorax. 2004 Jun;59(6):494-9. doi: 10.1136/thx.2003.011205.
- Kermelly SB, Lajoie AC, Boucher ME, Series F. Impact of continuous positive airway pressure mode on adherence to treatment in obstructive sleep apnea patients awaiting bariatric surgery. J Sleep Res. 2021 Oct;30(5):e13288. doi: 10.1111/jsr.13288. Epub 2021 Feb 6.
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
1. september 2014
Primær færdiggørelse (Faktiske)
16. marts 2018
Studieafslutning (Faktiske)
16. marts 2018
Datoer for studieregistrering
Først indsendt
25. juni 2014
Først indsendt, der opfyldte QC-kriterier
1. august 2014
Først opslået (Skøn)
5. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APAP-21014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Obstruktiv søvnapnø
-
University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Nutrition Institute, SloveniaValens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... og andre samarbejdspartnereRekrutteringSøvnkvalitet | Sleep Onset LatencySlovenien
-
Mahidol UniversityRamathibodi HospitalIkke rekrutterer endnuSøvninerti | Søvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | NatskiftarbejdeThailand
-
University of ArizonaNational Heart, Lung, and Blood Institute (NHLBI)Ikke rekrutterer endnu
-
Haseki Training and Research HospitalIkke rekrutterer endnuRichards-Campbell Sleep Questionnaire (RCSQ)
-
National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
-
The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
-
Institute of Nutrition, Slovenia (Nutris)Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... og andre samarbejdspartnereIkke rekrutterer endnuSøvnkvalitet | Sleep Onset LatencySlovenien
-
Fu Jen Catholic University HospitalIkke rekrutterer endnuSedation | DISE | OSAS (Obstructive Sleep Apneas Syndrome)Taiwan
Kliniske forsøg med Positive airway pressure for the treatment of OSA
-
Memorial Sloan Kettering Cancer CenterAfsluttetFamilierne eller pårørende til patienter behandlet på MSKCC for ikke-kutane pladecellekarcinomer i | Øvre aerofordøjelseskanalForenede Stater
-
Cuiling FengLinfen Central Hospital; Zhuhai Hospital of Integrated Traditional Chinese... og andre samarbejdspartnereIkke rekrutterer endnu