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

NCT03506906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-10-07

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Wissenschaftliches Institut Bethanien e.V

    lead OTHER

Principal Investigators

  • Winfried J Randerath, Prof. Dr. · Krankenhaus Bethanien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-11
Primary Completion
2019-09-25
Completion
2020-09-21

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03506906 on ClinicalTrials.gov