About this trial
The combination of COPD and obstructive sleep apnea (OSA) can lead to undesirable interactions with the treatment approach. The investigators know that continuous positive airway pressure (CPAP) can increase dynamic hyperinflation in COPD patients, and in mechanical ventilation, the increase in PEEP can worsen dynamic hyperinflation. On the other hand, the team know that the severity of COPD obstruction and hyperinflation alter sleep efficiency, with periods of wakefulness during sleep, and during these periods, the patient would not have upper airway obstruction, which could affect the therapy they are receiving in CPAP mode for OSA. Moreover, it was observed that with greater hyperinflation, the rate of obstructive events decreases, dynamically affecting the ventilatory situation with upper airway resistance. Recent studies have determined the safety and efficacy of auto-adjusting systems in the treatment of overlap syndrome, which could be more adaptable to the changing pulmonary mechanics of these patients. Aerobic capacity is a good predictor to the health status in these patients and the investigators know it is reduced in patients with AOS, where CPAP treatment according to studies improves the peak VO2. Therefore, the objective is to compare a ventilation system with fixed pressures established through polysomnography in patients with overlap syndrome and dynamic hyperinflation to a dynamic ventilation system using the fixed pressure limits typically established, based on their impact on the aerobic capacity (peak VO2) of these patients after 1 month of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stability of at least 4 weeks without hospital admission.
Previously presented PCO2 > 52.
Age between 50 and 80 years.
Agree to participate in the study and sign the informed consent.
Disqualifiers
Refusal to participate in the study.
Uncontrolled structural or coronary heart disease (no changes in medication in the last 15 days).
LVEF < 45%.
Central sleep apnea syndrome (≥ 50% central events).
Trial design
Crossover
Treatments tested in this trial
Fixed pressure obtained in the polysomnography for 28 days
Procedure/Surgeryhome nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days
Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode
Procedure/Surgerydynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode (program B) for 28 days, using the apnea threshold obtained in the titration as the maximum EPAP pressure and adjusting the support pressure for inferred Vt to 8 ml/kg of ideal body weight. After the first 28 days, a polysomnography will be performed under therapy with the device, and the next morning, cycle ergometry will be conducted.
Treatment groups
Trial outcomes
Primary outcomes
Peak VO2
Peak VO2 as the primary variable obtained from cycle ergometry.
Secondary outcomes
VO2 max
VO2 max as a secondary variable obtained from cycle ergometry
Anaerobic threshold
Anaerobic threshold as a secondary variable obtained from cycle ergometry.
VE/VCO2
The slope of VE/VCO2 obtained from cycle ergometry and resting PEtCO2.
BODE INDEX. (body mass index,)
Polysomnography
Other outcomes
Epworth scale
Based on a scale of (0 to 24 points)
Analytical parameters
CAT u/ml
Analytical parameters
ProBNP pg/mL
Analytical parameters
C-reactive protein mg/dL
Sponsors and contacts
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