Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
PROCEDUREFixed pressure obtained in the polysomnography for 28 days
home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days
PROCEDUREDynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode
dynamic 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.
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Both sexes.
Exclusion criteria
* 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). * Uncontrolled pulmonary hypertension. * Inability to perform the tests. * Having had an exacerbation 4 weeks prior. * Severe psychiatric illness. * Cognitive impairment. * Not speaking Spanish. * Illiteracy. * Active smoker (or \< 6 months since quitting smoking).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak VO2 | 0,29 and 57 days. | Peak VO2 as the primary variable obtained from cycle ergometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VO2 max | 0,29 and 57 days. | VO2 max as a secondary variable obtained from cycle ergometry |
| Anaerobic threshold | 0,29 and 57 days. | Anaerobic threshold as a secondary variable obtained from cycle ergometry. |
| VE/VCO2 | 0,29 and 57 days. | The slope of VE/VCO2 obtained from cycle ergometry and resting PEtCO2. |
| BODE INDEX. (body mass index,) | 0,29 and 57 days. | Polysomnography |
| BODE INDEX. (dyspnea, ) | 0,29 and 57 days. | number of residual respiratory events, time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time. |
| BODE INDEX. (exercise capacity) | 0,29 and 57 days. | — |
| BODE INDEX. ( air-flow obstruction) | 0,29 and 57 days. | Time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Epworth scale | 0,29 and 57 days. | Based on a scale of (0 to 24 points) |
| Analytical parameters | 0,29 and 57 days. | CAT u/ml |
Countries
Spain
Contacts
Primary ContactHerminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD
Backup ContactFrancisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD
Outcome results
None listed