Chronic Obstructive Pulmonary DiseaseNCT01961245
Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
A study testing nocturnal non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Non-invasive Ventilation
- What is being tested?
- nocturnal non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- chronic obstructive pulmonary disease stage IV
- indication for the use of a nocturnal non-invasive ventilation (according to the German guidelines Schoenhofer et al. 2008)
- patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day)
- chronic obstructive pulmonary disease stage IV (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor)
Who cannot join
- acute exacerbation of chronic obstructive pulmonary disease
- severe heart failure
- body-mass-index >35 m²/kg
- fever
- acute exacerbation of chronic obstructive pulmonary disease
- indication for the use of a non-invasive ventilation
Show all 9Show fewer
- severe heart failure
- body-mass-index >35 m²/kg
- fever
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Klinik Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
Klaus Kenn, Dr., +49 8652 931541, kkenn@schoen-kliniken.de
Klaus Kenn, Dr.
About this study
It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program.
A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.
- Conditions
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Non-invasive Ventilation, Energy Expenditure
- Being tested
- nocturnal non-invasive ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nocturnal non-invasive ventilationDevice
patients will undergo a non-invasive ventilation during the night
| Study group | Role | What they receive |
|---|---|---|
| nocturnal non-invasive ventilation | Active comparator | patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation Receives: Device: nocturnal non-invasive ventilation |
| no nocturnal non-invasive ventilation | No intervention | patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure during night
energy expenditure will be assessed by Sensewear Armband
Measured: day 1-3 and day 14-16
Secondary outcomes (5)
energy expenditure during day
energy expenditure will be assessed by SenseWear Armband
Measured: day 1-3 and day 14-16
lung function
measured by a bodyplethysmograph
Measured: day 1-3 and day 14-16
sleep quality
measured by Severe Respiratory Insufficiency Questionnaire
Measured: day 1-3 and day 14-16
arterial pressure of carbon dioxide during night
measured transcutaneously by a Sentec device
Measured: day 1-3 and day 14-16
movement activity during the night
night movement activity will be measured in a subgroup with the Dynaport device
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961245
- Sponsor's protocol ID
- BGL-NIV2
- Status last verified
- Feb 2019
- First submitted
- 30 Sep 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nocturnal Non-invasive Ventilation on Energy Expenditure in Patients With Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01961245
- Acronym / sponsor ID
- BGL-NIV2
- Conditions
- Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Non-invasive Ventilation, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Oct 2013 (estimated)
- 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.
It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program.
A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nocturnal non-invasive ventilation | Active comparator | Device: nocturnal non-invasive ventilationpatients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation |
| no nocturnal non-invasive ventilation | No intervention | –patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- chronic obstructive pulmonary disease stage IV
- indication for the use of a nocturnal non-invasive ventilation (according to the German guidelines Schoenhofer et al. 2008)
- patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day)
- chronic obstructive pulmonary disease stage IV (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor)
Key exclusion criteria (9 listed)
- acute exacerbation of chronic obstructive pulmonary disease
- severe heart failure
- body-mass-index >35 m²/kg
- fever
- acute exacerbation of chronic obstructive pulmonary disease
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 |
|---|---|---|
| nocturnal non-invasive ventilationpatients will undergo a non-invasive ventilation during the night | Device | nocturnal non-invasive ventilation |
Primary outcome
energy expenditure during night
Time frame: day 1-3 and day 14-16
energy expenditure will be assessed by Sensewear Armband
5 secondary outcomes
energy expenditure during day
Time frame: day 1-3 and day 14-16
lung function
Time frame: day 1-3 and day 14-16
sleep quality
Time frame: day 1-3 and day 14-16
arterial pressure of carbon dioxide during night
Time frame: day 1-3 and day 14-16
movement activity during the night
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nocturnal non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, run by Schön Klinik Berchtesgadener Land 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Kenn, Dr. (+49 8652 931451, kkenn@schoen-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy expenditure during night (time frame: day 1-3 and day 14-16). 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 27 Feb 2019.