NCT06713486Not yet recruiting
Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Diseases
- COPD
- NCT number
- NCT06713486
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Dec 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having had an exacerbation 4 weeks prior.
Other illness
- Uncontrolled structural or coronary heart disease (no changes in medication in the last 15 days).
- Central sleep apnea syndrome (≥ 50% central events).
- Uncontrolled pulmonary hypertension.
- Severe psychiatric illness.
- Cognitive impairment.
Lab values
- LVEF \< 45%.
Other
- Refusal to participate in the study.
- Inability to perform the tests.
- Not speaking Spanish.
- Illiteracy.
- Active smoker (or \< 6 months since quitting smoking).
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca. Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.