Clinical trial NCT03506906: The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation
Official title: The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoventilation Syndrome
Chronic Obstructive Pulmonary Disease
Obesity Hypoventilation Syndrome
Restrictive Lung Disease
Neuromuscular Diseases
Keywords: Chronic hypoventilation syndrome
Polysomnography
Transcutaneous Capnometry
Noninvasive Ventilation
home mechanical ventilation
Ventilator´s set-up
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hypercapnic respiratory failure secondary to one or more identified condition(s) (chronic obstructive pulmonary disease, obesity hypoventilation syndrome, neuromuscular diseases, restrictive lung diseases)
* Home mechanical ventilation for ≥ 6 months
* Stable condition for ≥ 1 month

Exclusion Criteria:

* Previous adjustment of the noninvasive ventilation therapy under sleep studies in the last 6 months
* Current respiratory exacerbation
* Any current comorbidity decompensation
* Any medical or psychological condition impairing the patient's ability to provide informed consent
* Missing signed informed consent
* Total sleep time during polysomnography \<180 min

Primary outcomes:
measure: Adjustment of non-invasive ventilation
timeFrame: One day
Secondary outcomes:
measure: Non-invasive ventilation compliance
timeFrame: 6 months
measure: Health-related quality of life: questionnaire
timeFrame: 6 months
measure: arterial level of carbon dioxide
timeFrame: 6 months
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Krankenhaus Bethanien
state: NRW
Study officials:
affiliation: Krankenhaus Bethanien
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: