跳至主要内容
临床试验/NCT03381937
NCT03381937Unknown不适用

Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation

Centre d'Investigation Clinique et Technologique 8052 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
Phonation duration

研究概览

简要总结

We want to demonstrate that modifications of the ventilation parameters are liable to improve the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular patients who are dependent on non invasive ventilation.

详细描述

Speech and communication quality depend on respiration efficiency. The respiratory involvement observed in neuromuscular disorders can impair speech quality in patients, while the underlying disease may also contribute to alter phonation.

Nowadays, the first line treatment of neuromuscular chronic neuromuscular respiratory failure is noninvasive ventilation (NIV). With disease progression, it is used with increasingly duration during daytime. In that situation, mouthpiece ventilation is preferred as it allows efficient ventilation while being more comfortable for patients who can chose when they want to be ventilated. However, in that situation, patients do not receive ventilatory support while they are speaking which puts them in a less favorable situation for speech. We think that pre-phonation inspiratory volume is an essential part of speech quality. Without mechanical ventilation, this volume is reduced as a consequence of respiratory failure but it is liable to increase significantly if the patient used the volume delivered by the ventilator .

We believe that phonation is improved by NIV by applying specific ventilation parameters in patients dependant on mechanical ventilation. The modification could be used by neuromuscular patients to improve speech quality; the patients would then be able to use their usual ventilatory support to improve phonation and modulation of their speech.

In this crossover open labelled, randomised study, done in a single center (home ventilation unit of the referral center of Hospital Raymond Poincaré HUPIFO (University Hospital of Western Paris and Ile de France) (Garches, France)), phonation characteristics will be studied in 3 situations (during spontaneous breathing without ventilatory support, with the usual NIV parameters, with speech-specific NIV parameters) during which speech trials will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

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

  • adult patients (age > or equal to 18)
  • chronic restrictive respiratory failure due to neuromuscular disease
  • spontaneous breathing autonomy of at least one hour during the days
  • stable clinical state
  • patient with middle school education level (able to read)
  • patients using life support ventilator ((Astral 150 (ResMed®), Elysée (ResMed®), Trilogy (Philips Respironics®), VentilogicLS (Weinman®), Vivo 40 (Breas®), PB560 ou Légendair (Covidien®), Monal T50 (Air liquide system®))

排除标准

  • refusal to participate
  • unability to cooperate
  • illiterate patients
  • tracheostomised patients
  • spontaneous breathing autonomy < 1h
  • cardiovascular instability
  • not registered with the social security system

研究组 & 干预措施

Spontaneous breathing

No Intervention

Spontaneous breathing without mechanical ventilation

Conventional mechanical ventilation

Experimental

Conventional mechanical ventilation, with patient ventilator usual parameters

干预措施: speech trial (Other)

Speech specific mechanical ventilation

Experimental

Mechanical ventilation with specific parameters to improve speech

干预措施: speech trial (Other)

结局指标

主要结局

Phonation duration

时间窗: 1 hour

evaluation by the measurement of the longest duration of a sustained A sound. The subject is asked to sustain a vowel as long as possible during a respiratory cycle while being recorded. Phonation duration is measured (in seconds) on the recording

次要结局

  • Speech Intelligibility(1 hour)
  • Reading duration(1 hour)
  • Quality of prosodia(1 hour)
  • Phonation quality(1 hour)
  • Phonation flow(1 hour)
  • Breathing quality(1 hour)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验