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

NCT ID: NCT03506906

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-11
• Study Completion Date: 2020-09-21

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional-approach

The non-invasive ventilation therapy will be optimized according to routine tests (blood gas analysis, lung function, ventilator's built-in software analysis)

Group Type: ACTIVE_COMPARATOR

Routine tests

Intervention Type: DIAGNOSTIC_TEST

Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)

Sleep studies-based approach

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.

Group Type: EXPERIMENTAL

Sleep studies under noninvasive ventilation therapy

Intervention Type: DIAGNOSTIC_TEST

Polysomnography Transcutaneous capnography

Routine tests

Intervention Type: DIAGNOSTIC_TEST

Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)

Interventions

Sleep studies under noninvasive ventilation therapy

Polysomnography Transcutaneous capnography

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Winfried J Randerath, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Bethanien

Locations

Krankenhaus Bethanien

Solingen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

WI_18-023

Identifier Type: -

Identifier Source: org_study_id