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

Not Applicable

Completed

• Conditions: Hypoventilation Syndrome; Neuromuscular Diseases; Chronic Obstructive Pulmonary Disease; Restrictive Lung Disease; Obesity Hypoventilation Syndrome
• Interventions: Diagnostic Test: Routine tests; Diagnostic Test: Sleep studies under noninvasive ventilation therapy

• Registration Number: NCT03506906
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-24
• Study Start: 2018-11-11
• Primary Completion: 2019-09-25
• Study Completion: 2020-09-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional-approach	Routine tests	The non-invasive ventilation therapy will be optimized according to routine tests (blood gas analysis, lung function, ventilator's built-in software analysis)
Sleep studies-based approach	Routine tests	Additionally to the routine tests, the results of a nocturnal polysomnography and transcutaneous capnometry under the non-invasive ventilation therapy will be considered for the therapy optimization.
Sleep studies-based approach	Sleep studies under noninvasive ventilation therapy	Additionally to the routine tests, the results of a nocturnal polysomnography and transcutaneous capnometry under the non-invasive ventilation therapy will be considered for the therapy optimization.

Primary Outcome Measures

Name	Time	Method
Adjustment of non-invasive ventilation	One day	Each case will be evaluated separately by 2 investigators. One of them will be provided with the diurnal evaluations only (as routinely); the second investigator will additionally have access to the sleep studies. Each investigator will classify the case as one of the following labels (primary outcome): 1. Non-invasive ventilation therapy optimization is not required (all ventilator's parameters should stay unchanged); 2. Optimization of non-invasive ventilation therapy is required (one or more of the ventilator's parameters should be re-set, irrespective of the magnitude)

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life: questionnaire	6 months	In the next follow-up visit, the health-related quality of life of both groups will be evaluated with the severe respiratory insufficiency questionnaire.
arterial level of carbon dioxide	6 months	In the next follow-up visit, the arterial level of carbon dioxide of both groups will be evaluated in the blood gas analysis
Non-invasive ventilation compliance	6 months	The ventilator's optimization will be performed randomly according to the clinical-based approach or the sleep studies-based approach. In the next follow-up visit, both arms will be re-evaluated. The change in non-invasive ventilation therapy compliance will be explored based on the ventilator´s built-in software data.

Trial Locations

Locations (1)

Krankenhaus Bethanien; 🇩🇪 Solingen, NRW, Germany