Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status: Not yet enrolling

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Procedure: Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode; Procedure: Fixed pressure obtained in the polysomnography for 28 days

Study type: Interventional

Funder types: Other

Identifiers

NCT06713486

EDIN-IDIN

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

FIXED PRESSURE

Experimental group

Description:

Home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days

Treatment:

Procedure: Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode

B

Active Comparator group

Description:

Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode for 28 days.

Treatment:

Procedure: Fixed pressure obtained in the polysomnography for 28 days