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临床试验/NCT06713486
NCT06713486尚未招募不适用

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

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
2
主要终点
Peak VO2

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stability of at least 4 weeks without hospital admission.
  • Previously presented PCO2 >
  • Age between 50 and 80 years.
  • Agree to participate in the study and sign the informed consent.
  • Both sexes.

排除标准

  • 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).

结局指标

主要结局

Peak VO2

时间窗: 0,29 and 57 days.

Peak VO2 as the primary variable obtained from cycle ergometry.

次要结局

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

研究者

发起方
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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