NCT03506906

The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Wissenschaftliches Institut Bethanien e.V · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. These patients are complex; and the ventilator´s parameters should be set-up according to the underlying disease and particular patient's characteristics. The non-invasive ventilation therapy is mostly titrated while the patient is awake, hence Problems, such as Patient-Ventilator asynchrony, arising while sleeping on the ventilator therapy would remain undetected. Sleep studies, such as polysomnography or polygraphy and transcutaneous carbon dioxide monitoring could be valuable tools to fine-tune the ventilator's settings. This could foster the ventilator´s effectivity and patient satisfaction, thus therapy's adherence. Nevertheless the sleep studies are expensive, time-consuming and not widely available. The aim of this study is to learn the findings of sleep studies when they are performed on stable patients on home mechanical ventilation as part of their routine check-ups. In this context, it will be assessed whether the sleep studies' findings lead to a change (adjustment) of the ventilator´s therapy. Moreover, this study aims to investigate whether the absence of sleep studies would result in missing important events that require an adjustment of therapy. The results of this study could provide information that lead to a more standardized protocol of follow-up checks of patients on home mechanical ventilation in a cost-effective manner.

Conditions

• Hypoventilation Syndrome
• Chronic Obstructive Pulmonary Disease
• Obesity Hypoventilation Syndrome
• Restrictive Lung Disease
• Neuromuscular Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sleep studies under noninvasive ventilation therapy	Polysomnography Transcutaneous capnography
DIAGNOSTIC_TEST	Routine tests	Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)

Timeline

• Start date: 2018-11-11
• Primary completion: 2019-09-25
• Completion: 2020-09-21
• First posted: 2018-04-24
• Last updated: 2021-10-07

Locations

1 site across 1 country: Germany