Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery (APAP-CPAP)

August 1, 2019 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Institut Universitaire de cardiologie et de pneumologie de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Automatic positive airway pressure
Automatic positive airway pressure treatment of obstructive sleep apnea
Device: Positive airway pressure for the treatment of OSA
Other Names:
  • Positive pressure device used: ResMed Autoset S9.
Active Comparator: Continuous positive airway pressure
Continuous positive airway pressure for the treatment of obstructive sleep apnea
Device: Positive airway pressure for the treatment of OSA
Other Names:
  • Positive pressure device used: ResMed Autoset S9.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance of APAP and CPAP
Time Frame: at time of surgery
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
at time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pressure level with APAP and CPAP
Time Frame: 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
Time Frame: 1 month
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
1 month
Residual apnea + hypopnea index
Time Frame: 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
Time Frame: 1 month
Number of residual respiratory events recorded by the positive pressure device during the treatment period
1 month
epworth sleepiness score
Time Frame: at time of surgery
Somnolence measured by Epworth Sleepiness Scale;
at time of surgery
quality of life score with APAP and CPAP
Time Frame: 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
Time Frame: at time of surgery
Positive airway pressure adverse effects measured by a visual analogic scale.
at time of surgery
Compliance of APAP and CPAP
Time Frame: 1 month
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

GROUPE DE RECHERCHE EN SANTÉ RESPIRATOIRE DE L'UNIVERSITÉ LAVAL (GESER)

Investigators

  • Principal Investigator: Frédéric Séries, MD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APAP-21014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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