Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery

Obstructive Sleep Apnea Clinical Trial

— APAP-CPAP  

Official title:

Impact of Automatic Positive Airway Pressure on Treatment Compliance in Obstructive Sleep Apnea Patients Awaiting Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209220
• Other study ID #: APAP-21014
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 16, 2018

Study information

• Verified date: August 2019
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Automatic Positive Airway Pressure
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Treatment Compliance

Intervention

Device:
• Positive airway pressure for the treatment of OSA

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	GROUPE DE RECHERCHE EN SANTÉ RESPIRATOIRE DE L’UNIVERSITÉ LAVAL (GESER)

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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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. — View Citation

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. — View Citation

Lacasse Y, Bureau MP, Sériès F. A new standardised and self-administered quality of life questionnaire specific to obstructive sleep apnoea. Thorax. 2004 Jun;59(6):494-9. — View Citation

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. Epub 2002 Oct 4. — View Citation

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. Epub 2007 Nov 28. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance of APAP and CPAP	Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure	at time of surgery
Secondary	Mean pressure level with APAP and CPAP	Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.	at time of surgery
Secondary	Mean pressure level with APAP and CPAP	Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.	1 month
Secondary	Residual apnea + hypopnea index	Number of residual respiratory events recorded by the positive pressure device during the treatment period	at time of surgery
Secondary	Residual apnea + hypopnea index	Number of residual respiratory events recorded by the positive pressure device during the treatment period	1 month
Secondary	epworth sleepiness score	Somnolence measured by Epworth Sleepiness Scale;	at time of surgery
Secondary	quality of life score with APAP and CPAP	Quality of life measured by Questionnaire sur la Qualité de vie du Québec	at time of surgery
Secondary	Positive pressure therapy adverse events	Positive airway pressure adverse effects measured by a visual analogic scale.	at time of surgery
Secondary	Compliance of APAP and CPAP	Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure	1 month