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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Neuromuscular Diseases; Obesity Hypoventilation Syndrome; Restrictive Lung Disease; Hypoventilation Syndrome
• Intervention / Treatment: Diagnostic test: Routine tests; Diagnostic test: Sleep studies under noninvasive ventilation therapy

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Solingen, NRW, Germany, 42699
      • Krankenhaus Bethanien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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)
Experimental: 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.	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); Diagnostic test: Sleep studies under noninvasive ventilation therapy; Polysomnography Transcutaneous capnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjustment of non-invasive ventilation	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): Non-invasive ventilation therapy optimization is not required (all ventilator's parameters should stay unchanged); Optimization of non-invasive ventilation therapy is required (one or more of the ventilator's parameters should be re-set, irrespective of the magnitude)	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive ventilation compliance	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.	6 months
Health-related quality of life: questionnaire	In the next follow-up visit, the health-related quality of life of both groups will be evaluated with the severe respiratory insufficiency questionnaire.	6 months
arterial level of carbon dioxide	In the next follow-up visit, the arterial level of carbon dioxide of both groups will be evaluated in the blood gas analysis	6 months

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Investigators: Principal Investigator: Winfried J Randerath, Prof. Dr., Krankenhaus Bethanien

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2018
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Polysomnography; Noninvasive Ventilation; Chronic hypoventilation syndrome; Transcutaneous Capnometry; home mechanical ventilation; Ventilator´s set-up
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Obesity; Sleep Apnea, Obstructive; Syndrome; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: WI_18-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No