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

Обзор

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.

Вмешательства

• Процедура Fixed pressure obtained in the polysomnography for 28 days
  home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days
• Процедура 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.

Первичные конечные точки

• Peak VO2 [Срок оценки: 0,29 and 57 days.]

Вторичные конечные точки (7)

• VO2 max [Срок оценки: 0,29 and 57 days.]
• Anaerobic threshold [Срок оценки: 0,29 and 57 days.]
• VE/VCO2 [Срок оценки: 0,29 and 57 days.]
• BODE INDEX. (body mass index,) [Срок оценки: 0,29 and 57 days.]
• BODE INDEX. ( air-flow obstruction) [Срок оценки: 0,29 and 57 days.]
• BODE INDEX. (dyspnea, ) [Срок оценки: 0,29 and 57 days.]
• BODE INDEX. (exercise capacity) [Срок оценки: 0,29 and 57 days.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca. — Murcia

Идентификаторы

NCT: NCT06713486 · EDIN-IDIN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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