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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode; Procedure: Fixed pressure obtained in the polysomnography for 28 days

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD; Phone Number: Exts 369422/36 TFL: 968369500.; Email: fjose.ruiz1@um.es
• Study Contact Backup: Name: Francisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD; Phone Number: Exts 369422/36 968369500; Email: fjose.ruiz1@um.es

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.
    • Contact: Francisco José Ruiz López Ruiz Lopez, MD; Phone Number: Exts 369422/36 968369500; Email: fjose.ruiz1@um.es
    • Contact: Francisco José Ruiz López Ruiz Lopez, MD
    • Contact: Herminia Buchelli Ramirez Buchelli Ramirez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIXED PRESSURE; Home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days	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.
Active Comparator: B; Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode for 28 days.	Procedure: Fixed pressure obtained in the polysomnography for 28 days; home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2	Peak VO2 as the primary variable obtained from cycle ergometry.	0,29 and 57 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	VO2 max as a secondary variable obtained from cycle ergometry	0,29 and 57 days.
Anaerobic threshold	Anaerobic threshold as a secondary variable obtained from cycle ergometry.	0,29 and 57 days.
VE/VCO2	The slope of VE/VCO2 obtained from cycle ergometry and resting PEtCO2.	0,29 and 57 days.
BODE INDEX. (body mass index,)	Polysomnography	0,29 and 57 days.
BODE INDEX. ( air-flow obstruction)	Time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time.	0,29 and 57 days.
BODE INDEX. (dyspnea, )	number of residual respiratory events, time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time.	0,29 and 57 days.
BODE INDEX. (exercise capacity)		0,29 and 57 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth scale	Based on a scale of (0 to 24 points)	0,29 and 57 days.
Analytical parameters	CAT u/ml	0,29 and 57 days.
Analytical parameters	ProBNP pg/mL	0,29 and 57 days.
Analytical parameters	C-reactive protein mg/dL	0,29 and 57 days.
Analytical parameters	pH	0,29 and 57 days.
Analytical parameters	pO2 mmHg, pCO2 mmHg	0,29 and 57 days.
Analytical parameters	sHCO3 mmol/L	0,29 and 57 days.
Analytical parameters	SatO2 %	0,29 and 57 days.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Pulmonary Disease, Chronic Obstructive; Sleep Apnea Syndromes
• Other Study ID Numbers: EDIN-IDIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No