Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fixed pressure obtained in the polysomnography for 28 days, Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode.
- Who it may be relevant to
- Registry conditions: Pulmonary Disease, Chronic Obstructive. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Peak VO2 [Time frame: 0,29 and 57 days.]
Secondary outcome measures (7)
- VO2 max [Time frame: 0,29 and 57 days.]
- Anaerobic threshold [Time frame: 0,29 and 57 days.]
- VE/VCO2 [Time frame: 0,29 and 57 days.]
- BODE INDEX. (body mass index,) [Time frame: 0,29 and 57 days.]
- BODE INDEX. ( air-flow obstruction) [Time frame: 0,29 and 57 days.]
- BODE INDEX. (dyspnea, ) [Time frame: 0,29 and 57 days.]
- BODE INDEX. (exercise capacity) [Time frame: 0,29 and 57 days.]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca. — Murcia
Identifiers
NCT: NCT06713486 · EDIN-IDIN