COPDNCT02399514
Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema
A study testing Polysomnographic diagnostic in people with COPD and Emphysema, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial summary
Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Polysomnographic diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 5 Nov 2014to 9 Mar 2018
- 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
- Written consent
- RePneu Coil treatment according to clinical criteria
Who cannot join
- Pregnancy or nursing period
- Participation in another clinical trial within the last 4 weeks
- Incapable of giving consent
- Known OSA (AHI>10)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems
Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema.
Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after.
Read more
Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment.
Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).
- Being tested
- Polysomnographic diagnostic
- Keywords
- Sleep, emphysema, coils, lung volume reduction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnographic diagnosticOther
Also called PSG
Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment
| Study group | Role | What they receive |
|---|---|---|
| RePneum coils | Other | Patients who needed lung volume reduction with RePneum coils Receives: Other: Polysomnographic diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.
Sleep Efficiency is evaluated by the ratio of WASO (Time "wake after sleep onset") to Sleep Period Time (SPT).
Measured: 3 times in one year
Secondary outcomes (1)
Quality of life Questionnaire
The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.
Measured: 3 times in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study start5 Nov 2014
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Principal investigator, Karl Josef Franke, Helios Klinik Ambrock
- Investigators
- Karl-Josef Franke, MD, Principal investigator, Helios Klinik Ambrock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399514
- Sponsor's protocol ID
- JF001 sleep
- Status last verified
- Feb 2019
- First submitted
- 23 Mar 2015
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Franke KJ, Domanski U, Schroder M, Nilius G. Effects of endobronchial coils for endoscopic lung volume reduction on sleep in COPD patients with advanced pulmonary emphysema. Sleep Breath. 2021 Jun;25(2):727-735. doi: 10.1007/s11325-020-02176-0. Epub 2020 Aug 26.
PubMed 32845475
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems
- ClinicalTrials.gov ID
- NCT02399514
- Acronym / sponsor ID
- JF001 sleep
- Keywords
- Sleep, emphysema, coils, lung volume reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 26 Mar 2015 (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.
Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema.
Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after.
Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment.
Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RePneum coils | Other | Other: Polysomnographic diagnosticPatients who needed lung volume reduction with RePneum coils |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written consent
- RePneu Coil treatment according to clinical criteria
Key exclusion criteria (4 listed)
- Pregnancy or nursing period
- Participation in another clinical trial within the last 4 weeks
- Incapable of giving consent
- Known OSA (AHI>10)
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 |
|---|---|---|
| Polysomnographic diagnosticAlso: PSGPolysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment | Other | RePneum coils |
Primary outcome
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.
Time frame: 3 times in one year
Sleep Efficiency is evaluated by the ratio of WASO (Time "wake after sleep onset") to Sleep Period Time (SPT).
1 secondary outcome
Quality of life Questionnaire
Time frame: 3 times in one year
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 11 Feb 2019.
- Derived from this study: PubMed 32845475Franke KJ, Domanski U, Schroder M, Nilius G. Effects of endobronchial coils for endoscopic lung volume reduction on sleep in COPD patients with advanced pulmonary emphysema. Sleep Breath. 2021 Jun;25(2):727-735. doi: 10.1007/s11325-020-02176-0. Epub 2020 Aug 26.
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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.
Karl-Josef Franke, MD principal investigator
Helios Klinik Ambrock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnographic diagnostic in people with COPD and Emphysema, run by Institut für Pneumologie Hagen Ambrock eV 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 2 inclusion and 4 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 11 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?
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?
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment. (time frame: 3 times in one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399514, which also lists 1 linked publication.
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 11 Feb 2019.