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Completed

NCT Number: NCT02209220

Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive airway pressure for the treatment of OSA

Device

Other names: Positive pressure device used: ResMed Autoset S9.

Primary outcomes

  1. Compliance of APAP and CPAP

    Time frame: at time of surgery

    Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Residual apnea + hypopnea index

    Time frame: 1 month

    Number of residual respiratory events recorded by the positive pressure device during the treatment period

  5. epworth sleepiness score

    Time frame: at time of surgery

    Somnolence measured by Epworth Sleepiness Scale;

  6. 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

  7. Positive pressure therapy adverse events

    Time frame: at time of surgery

    Positive airway pressure adverse effects measured by a visual analogic scale.

  8. Compliance of APAP and CPAP

    Time frame: 1 month

    Total utilisation time, daily hours of utilisation, percentage of nights with positive pressure

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: APAP-CPAP

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2014
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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