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

NCT ID: NCT06713486

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-09-01

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FIXED PRESSURE

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

Group Type: EXPERIMENTAL

Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode

Intervention Type: PROCEDURE

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.

B

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

Group Type: ACTIVE_COMPARATOR

Fixed pressure obtained in the polysomnography for 28 days

Intervention Type: PROCEDURE

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

Interventions

Fixed pressure obtained in the polysomnography for 28 days

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

Intervention Type: PROCEDURE

Dynamic 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.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.

Murcia, Murcia, Spain

Countries

Spain

Central Contacts

Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD

Role: CONTACT

fjose.ruiz1@um.es

TFL: 968369500. ext. Exts 369422/36

Francisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD

Role: CONTACT

fjose.ruiz1@um.es

968369500 ext. Exts 369422/36

Facility Contacts

Francisco José Ruiz López Ruiz Lopez, MD

Role: primary

fjose.ruiz1@um.es

968369500 ext. Exts 369422/36

Francisco José Ruiz López Ruiz Lopez, MD

Role: backup

Herminia Buchelli Ramirez Buchelli Ramirez, MD

Role: backup

Other Identifiers

EDIN-IDIN

Identifier Type: -

Identifier Source: org_study_id