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临床试验/NCT05272761
NCT05272761Unknown不适用

Impact of Breathing Route on the Effectiveness of Treatment of Obstructive Sleep Apnea With CPAP and Oronasal Mask

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Impact of breathing route on residual AHI

研究概览

简要总结

To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using CPAP with oronasal mask on CPAP level, residual AHI, and peak flow. In addition, the impact of position (lateral vs supine position) will be evaluated during PSG.

详细描述

Application of Continuous Positive Upper Airway Pressure (CPAP) during sleep using nasal mask is the gold standard treatment for Obstructive Sleep Apnea (OSA). In clinical practice, many patients with OSA are considered mouth breathers and use an oronasal mask. However, CPAP delivered by the mouth violates the principal of CPAP use to treat OSA. This study is part of a line of research over the last decade that started with the observation of a patient that CPAP delivered by an oronasal mask failed to splint the airway open and to abolish OSA . We showed subsequently in acute studies during induced-sleep that oronasal CPAP only works when the patient breathes predominantly through the nose. These observations prompted our group to lead one workshop on the importance of mask selection. One meta-analysis from our group confirmed that oronasal CPAP is associated with a higher CPAP level, higher residual AHI, and poorer adherence than nasal CPAP. Despite all this evidence the investigators intrigued by the clinical observation that oronasal masks remains common and several patients on clinical practice are well adapted to oronasal CPAP. In this study, 20 patients with OSA well adapted to the oronasal mask will be recruited. The patients will be invited to be submitted to 2 independent CPAP titration sleep studies using a customized oronasal mask with a sealed and independent nasal and oral compartments coupled to 2 pneumotachographs. One CPAP titration will be with the nasal and oral routes open and one CPAP titration with only the oral compartment opened. Our hypotheses are that obstruction of nasal compartment during CPAP titration causuing mouth breathing will result in higher CPAP and higher residual apnea-hypopnea index. Patients with OSA under treatment with oronasal CPAP will undergo CPAP titration polysomnography on 2 different nights. In one night the patient will sleep with the oral and nasal compartments opened and in another night interposed by at least seven days, the patient with sleep with only the oral compartment opened. The order of the 2 sleep studies will be randomized. Thus, researchers will assess the impact of the airway (oral vs oronasal) on titrated CPAP level, residual AHI, and sleep efficiency in supine and lateral recumbency. In addition, the preferred airway during the oronasal mask will be analyzed. At the end of the study a nasal mask will be offered to all patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of moderate or severe OSA in treatment with CPAP in an oronasal mask
  • 18 Years to 85 Years (Adult, Older Adult) (Adult, Older Adult)

排除标准

  • Other sleep disturbance (insomnia, parasomnias, narcolepsy, central sleep apnea).
  • Uncontrolled clinical disease (diabetes, kidney or heart failure, recent stroke or coronary failure and recent postoperative period, oxygen dependent COPD).
  • Patients adapted to other types of masks.

结局指标

主要结局

Impact of breathing route on residual AHI

时间窗: 2 nights

To determine the impact of the CPAP route (oronasal vs oral) in patients diagnosed with moderate-severe OSA using oronasal mask on residual AHI ( Apnea-hypopnea Index).

Impact of breathing route on the CPAP

时间窗: 2 nights

To determine the impact of the CPAP route (oronasal vs oral) in patients during titration of the CPAP route (oronasal vs oral)

次要结局

  • Influence of position(2 nights)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geraldo Lorenzi Filho

Principal Investigator

University of Sao Paulo General Hospital

研究点 (1)

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