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

Primary Purpose

Obstructive Sleep Apnea, Treatment Compliance, Automatic Positive Airway Pressure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Positive airway pressure for the treatment of OSA
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Treatment compliance, Automatic positive airway pressure, Continuous positive airway pressure, Bariatric surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Automatic positive airway pressure

Continuous positive airway pressure

Arm Description

Automatic positive airway pressure treatment of obstructive sleep apnea

Continuous positive airway pressure for the treatment of obstructive sleep apnea

Outcomes

Primary Outcome Measures

Compliance of APAP and CPAP
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2014
Last Updated
August 1, 2019
Sponsor
Laval University
Collaborators
GROUPE DE RECHERCHE EN SANTÉ RESPIRATOIRE DE L'UNIVERSITÉ LAVAL (GESER)
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1. Study Identification

Unique Protocol Identification Number
NCT02209220
Brief Title
Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery
Acronym
APAP-CPAP
Official Title
Impact of Automatic Positive Airway Pressure on Treatment Compliance in Obstructive Sleep Apnea Patients Awaiting Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
GROUPE DE RECHERCHE EN SANTÉ RESPIRATOIRE DE L'UNIVERSITÉ LAVAL (GESER)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Treatment Compliance, Automatic Positive Airway Pressure
Keywords
Obstructive sleep apnea, Treatment compliance, Automatic positive airway pressure, Continuous positive airway pressure, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automatic positive airway pressure
Arm Type
Active Comparator
Arm Description
Automatic positive airway pressure treatment of obstructive sleep apnea
Arm Title
Continuous positive airway pressure
Arm Type
Active Comparator
Arm Description
Continuous positive airway pressure for the treatment of obstructive sleep apnea
Intervention Type
Device
Intervention Name(s)
Positive airway pressure for the treatment of OSA
Other Intervention Name(s)
Positive pressure device used: ResMed Autoset S9.
Primary Outcome Measure Information:
Title
Compliance of APAP and CPAP
Description
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
Time Frame
at time of surgery
Secondary Outcome Measure Information:
Title
Mean pressure level with APAP and CPAP
Description
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
Time Frame
at time of surgery
Title
Mean pressure level with APAP and CPAP
Description
Pressure applied (mean pressure and 90th/95th percentile), apnea hypopnea index, amount of mask leaks.
Time Frame
1 month
Title
Residual apnea + hypopnea index
Description
Number of residual respiratory events recorded by the positive pressure device during the treatment period
Time Frame
at time of surgery
Title
Residual apnea + hypopnea index
Description
Number of residual respiratory events recorded by the positive pressure device during the treatment period
Time Frame
1 month
Title
epworth sleepiness score
Description
Somnolence measured by Epworth Sleepiness Scale;
Time Frame
at time of surgery
Title
quality of life score with APAP and CPAP
Description
Quality of life measured by Questionnaire sur la Qualité de vie du Québec
Time Frame
at time of surgery
Title
Positive pressure therapy adverse events
Description
Positive airway pressure adverse effects measured by a visual analogic scale.
Time Frame
at time of surgery
Title
Compliance of APAP and CPAP
Description
Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Séries, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22956642
Citation
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery

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