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

NCT06713486 | Not Yet Recruiting

• 1 other identifier: EDIN-IDIN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peak VO2

  Peak VO2 as the primary variable obtained from cycle ergometry.

  0,29 and 57 days.

Secondary Outcomes (7)

• VO2 max

  0,29 and 57 days.

• Anaerobic threshold

  0,29 and 57 days.

• VE/VCO2

  0,29 and 57 days.

• BODE INDEX. (body mass index,)

  0,29 and 57 days.

• BODE INDEX. ( air-flow obstruction)

  0,29 and 57 days.

Other Outcomes (8)

• Epworth scale

  0,29 and 57 days.

• Analytical parameters

  0,29 and 57 days.

• Analytical parameters

  0,29 and 57 days.

Study Arms (2)

FIXED PRESSURE

EXPERIMENTAL

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

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

B

ACTIVE COMPARATOR

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

Procedure: Fixed pressure obtained in the polysomnography for 28 days

Interventions

Fixed pressure obtained in the polysomnography for 28 days PROCEDURE

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

B

Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode 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.

FIXED PRESSURE

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.

Murcia, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

TFL: 968369500.; fjose.ruiz1@um.es

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

CONTACT

968369500; fjose.ruiz1@um.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)