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临床试验/NCT03247907
NCT03247907终止不适用

Humidification Needs

Fisher and Paykel Healthcare1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
10
试验地点
1
主要终点
Evaluation of Nasal Dryness and Discomfort

研究概览

简要总结

A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • •Aged 18 and over

排除标准

  • •Inability to give consent
  • •Currently pregnant or think they may be pregnant
  • •Current nasal symptoms or chronic nasal disease
  • •Contraindicated for PAP therapy

研究组 & 干预措施

Condition H: CPAP with New level humidification

Active Comparator

CPAP with New level humidification with mouth leak

干预措施: Condition H: CPAP with New level humidification (Device)

Condition A: CPAP with No Humidification

Active Comparator

CPAP with No Humidification with no mouth leak

干预措施: Condition A: CPAP with No Humidification (Device)

Condition B: CPAP with No Humidification

Active Comparator

CPAP with No Humidification with mouth leak

干预措施: Condition B: CPAP with No Humidification (Device)

Condition C: CPAP with Cold Passover humidifier

Active Comparator

CPAP with Cold Passover humidifier with mouth leak

干预措施: Condition C: CPAP with Cold Passover (Device)

Condition D: CPAP with Modified Humidifier

Active Comparator

CPAP with Modified Humidifier with mouth leak

干预措施: Condition D: CPAP with Modified humidifier (Device)

Condition E: CPAP with Ambient Tracking

Active Comparator

CPAP with Ambient Tracking with mouth leak

干预措施: Condition E: CPAP with Ambient Tracking (Device)

Condition F: CPAP with Heated Humidification

Active Comparator

CPAP with Heated Humidification at default setting with mouth leak

干预措施: Condition F: CPAP with Heated Humidification (Device)

Condition G: CPAP with Heated Humidification

Active Comparator

CPAP with Heated Humidification at max setting with mouth leak

干预措施: Condition G: CPAP with Heated Humidification (Device)

结局指标

主要结局

Evaluation of Nasal Dryness and Discomfort

时间窗: 8 Days

Reported by participants using the Xero Questionnaire

Nasal Resistance

时间窗: 8 Days

Will be measured by rhinomanometer or acoustic rhinometry

次要结局

  • Preference of Testing Condition(8 Days)

研究者

发起方
Fisher and Paykel Healthcare
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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