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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT06713486
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study Start: 2024-12-01
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Peak VO2	0,29 and 57 days.	Peak VO2 as the primary variable obtained from cycle ergometry.

Secondary Outcome Measures

Name	Time	Method
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. ( 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.
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.

Trial Locations

Locations (1)

Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.; 🇪🇸 Murcia, Spain