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NCT06713486: EDIN-IDIN

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

Not yet recruiting NA Last updated 3 December 2024
What this trial tests

NA trial testing Fixed pressure obtained in the polysomnography for 28 days in Pulmonary Disease, Chronic Obstructive in 20 participants. Not yet recruiting.

Timeline
1 December 2024
Primary endpoint
1 June 2026
1 September 2026

Quick facts

Lead sponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment20
Start date1 December 2024
Primary completion1 June 2026
Estimated completion1 September 2026
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia — full company profile →

Who can join

Adults 50 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06713486.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing