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

Primary Purpose

Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sleep studies under noninvasive ventilation therapy
Routine tests
Sponsored by
Wissenschaftliches Institut Bethanien e.V
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoventilation Syndrome focused on measuring Chronic hypoventilation syndrome, Polysomnography, Transcutaneous Capnometry, Noninvasive Ventilation, home mechanical ventilation, Ventilator´s set-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus Bethanien

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional-approach

Sleep studies-based approach

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
April 12, 2018
Last Updated
October 6, 2021
Sponsor
Wissenschaftliches Institut Bethanien e.V
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1. Study Identification

Unique Protocol Identification Number
NCT03506906
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wissenschaftliches Institut Bethanien e.V

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional-approach
Arm Type
Active Comparator
Arm Description
The non-invasive ventilation therapy will be optimized according to routine tests (blood gas analysis, lung function, ventilator's built-in software analysis)
Arm Title
Sleep studies-based approach
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sleep studies under noninvasive ventilation therapy
Intervention Description
Polysomnography Transcutaneous capnography
Intervention Type
Diagnostic Test
Intervention Name(s)
Routine tests
Intervention Description
Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)
Primary Outcome Measure Information:
Title
Adjustment of non-invasive ventilation
Description
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)
Time Frame
One day
Secondary Outcome Measure Information:
Title
Non-invasive ventilation compliance
Description
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.
Time Frame
6 months
Title
Health-related quality of life: questionnaire
Description
In the next follow-up visit, the health-related quality of life of both groups will be evaluated with the severe respiratory insufficiency questionnaire.
Time Frame
6 months
Title
arterial level of carbon dioxide
Description
In the next follow-up visit, the arterial level of carbon dioxide of both groups will be evaluated in the blood gas analysis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried J Randerath, Prof. Dr.
Organizational Affiliation
Krankenhaus Bethanien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Bethanien
City
Solingen
State/Province
NRW
ZIP/Postal Code
42699
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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