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临床试验/NCT03072173
NCT03072173Unknown不适用

The Role of the Nose in Snoring and Sleep Apnea

Lovisenberg Diakonale Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Level in therapeutic CPAP pressure

研究概览

简要总结

We intend to study, in depth, the quantitative and qualitative properties of nasal respiration in sleep-disordered breathing and sleep apnea and its relation to (CPAP) treatment with the final goal of improving patient outcome.

To do this we will temporarily alter patients' nasal airflow during monitored sleep to lower CPAP air pressure, making CPAP treatment more acceptable to the patient. Additionally we plan to implement highly advanced computerized modelling in collaboration with the OSASMOD research consortium at St. Olavs Hospital/NTNU and SINTEF to predict the results of our alterations and ultimately, to use these predictions to improve both the planning and the outcomes of nasal surgery.

详细描述

Based on results from previous studies we hypothesize that the nose plays a more significant role in normal sleep respiration and in particular a larger role in sleep disordered breathing than previously recorded.

The overall aim of this project is to gain insight into nasal respiration during wake and sleep, its anatomy, physiology and pathophysiology.

Additionally, we will look at olfactory dysfunction, or reduced sense of smell, a known problem in OSAS patients (n=30), and try to determine if this dysfunction has to do with disturbed sleep architecture or as a result of frequent deoxygenations during the night.

To do this we propose to implement current diagnostic tools available in the diagnostics of sleep disordered breathing such as polysomnography (PSG), in combination with rhinological investigations with 4-phase rhinomanometry and techniques such as two-way fluid structure interaction (FSI) computational fluid dynamic (CFD) analysis of patients. For olfactory testing we will use standardized smell tests. These examinations in combination will give us a more detailed view of the factors that influence nasal respiration.

Additionally, we will use an interventional approach in the proposed study. Patient nasal resistance will be modified under monitored sleep by implementing conventional decongestant nasal spray in an double blinded RCT in order to study the effect of varying nasal resistance on nocturnal respiration and sleep architecture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Patients with manifest OSAS and in need of CPAP-treatment

排除标准

  • Not speaking Norwegian Language, Congestive heart failure (ejection fraction <40%)

研究组 & 干预措施

PSG with Xylometazoline then placebo

Experimental

Patients are administered nasal CPAP with humidifier prior to PSG

Patients in this arm receive Xylometazoline on night 2 of PSG and placebo on night 3 of PSG.

干预措施: Xylometazoline (Drug)

PSG with Xylometazoline then placebo

Experimental

Patients are administered nasal CPAP with humidifier prior to PSG

Patients in this arm receive Xylometazoline on night 2 of PSG and placebo on night 3 of PSG.

干预措施: placebo (saline) (Drug)

PSG with placebo then Xylometazoline

Experimental

Patients are administered nasal CPAP with humidifier prior to PSG

Patients in this arm receive placebo on night 2 of PSG and Xylometazoline on night 3 of PSG.

干预措施: Xylometazoline (Drug)

PSG with placebo then Xylometazoline

Experimental

Patients are administered nasal CPAP with humidifier prior to PSG

Patients in this arm receive placebo on night 2 of PSG and Xylometazoline on night 3 of PSG.

干预措施: placebo (saline) (Drug)

结局指标

主要结局

Level in therapeutic CPAP pressure

时间窗: 6 months

Therapeutic CPAP pressure levels are measured automatically in CPAP device

次要结局

未报告次要终点

研究者

发起方
Lovisenberg Diakonale Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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