Hypoventilation SyndromeNCT03506906
The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation
A study testing Sleep studies under noninvasive ventilation therapy and Routine tests in people with Hypoventilation Syndrome and Chronic Obstructive Pulmonary Disease, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
Patients suffering chronic hypercapnic respiratory insufficiency (e.g. in chronic obstructive pulmonary disease, obesity hypoventilation syndrome) benefit from home mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoventilation Syndrome, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome
- What is being tested?
- Sleep studies under noninvasive ventilation therapy and Routine tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2018to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Sleep studies under noninvasive ventilation therapy, Routine tests
- Keywords
- Chronic hypoventilation syndrome, Polysomnography, Transcutaneous Capnometry, Noninvasive Ventilation, home mechanical ventilation, Ventilator´s set-up
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep studies under noninvasive ventilation therapyDiagnostic test
Polysomnography Transcutaneous capnography
Routine testsDiagnostic test
Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| Conventional-approach | Active comparator | The non-invasive ventilation therapy will be optimized according to routine tests (blood gas analysis, lung function, ventilator's built-in software analysis) Receives: Diagnostic Test: Routine tests |
| Sleep studies-based approach | Experimental | 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. Receives: Diagnostic Test: Sleep studies under noninvasive ventilation therapy; Diagnostic Test: Routine tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One day
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start11 Nov 2018
- Primary completion25 Sep 2019
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoventilation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Krankenhaus Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506906
- Sponsor's protocol ID
- WI_18-023
- Status last verified
- Oct 2021
- First submitted
- 12 Apr 2018
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Debated Role of Sleep Studies in Patients Under Established Home Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03506906
- Acronym / sponsor ID
- WI_18-023
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional-approach | Active comparator | Diagnostic Test: Routine testsThe 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 | Experimental | Diagnostic Test: Sleep studies under noninvasive ventilation therapy, Diagnostic Test: Routine testsAdditionally 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep studies under noninvasive ventilation therapyPolysomnography Transcutaneous capnography | Diagnostic test | Sleep studies-based approach |
| Routine testsSpirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire) | Diagnostic test | Conventional-approach, Sleep studies-based approach |
Primary outcome
Adjustment of non-invasive ventilation
Time frame: 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)
3 secondary outcomes
Non-invasive ventilation compliance
Time frame: 6 months
Health-related quality of life: questionnaire
Time frame: 6 months
arterial level of carbon dioxide
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Hypoventilation Syndrome
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Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
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Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
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RecruitingObservational study
Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried J Randerath, Prof. Dr. principal investigator
Krankenhaus Bethanien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep studies under noninvasive ventilation therapy and Routine tests in people with Hypoventilation Syndrome and Chronic Obstructive Pulmonary Disease, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjustment of non-invasive ventilation (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.