Clinical trial NCT06713486: Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
Official title: Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Peak VO2
timeFrame: 0,29 and 57 days.
Secondary outcomes:
measure: VO2 max
timeFrame: 0,29 and 57 days.
measure: Anaerobic threshold
timeFrame: 0,29 and 57 days.
measure: VE/VCO2
timeFrame: 0,29 and 57 days.
measure: BODE INDEX. (body mass index,)
timeFrame: 0,29 and 57 days.
measure: BODE INDEX. ( air-flow obstruction)
timeFrame: 0,29 and 57 days.
measure: BODE INDEX. (dyspnea, )
timeFrame: 0,29 and 57 days.
measure: BODE INDEX. (exercise capacity)
timeFrame: 0,29 and 57 days.
Other outcomes:
measure: Epworth scale
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
measure: Analytical parameters
timeFrame: 0,29 and 57 days.
Locations:
city: Murcia
country: Spain
facility: Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.
Study officials:
References: