Sleep-Disordered BreathingNCT02923505
Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)
An observational study of Sleep-Disordered Breathing and Pulmonary Disease, Chronic Obstructive, run by Wissenschaftliches Institut Bethanien e.V at 5 sites in 3 countries.
Trial summary
The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Sleep-Disordered Breathing, Pulmonary Disease, Chronic Obstructive, Heart Failure
- What is being tested?
- polygraphy or polysomnography
- Type of treatment
- Surgery or procedure
- How many people
- 383 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 16 May 2016to 30 Jun 2017
- Phase
- Observational
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient from primary care clinics and sleep medicine centers
Who may be able to join
- subjects between 21 to 75 years;
- consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/2015.
- diagnosis of COPD and/or HF
Who cannot join
- age <21 or >75 years
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany3 sites
Interdisziplinäres Schlafmedizinisches Zentrum, Charité Universitätsmedizin Berlin
Berlin, 10117
Schlafmedizinisches Zentrum der Klinik und Polyklinik für Innere Medizin II, Pneumologie, Universitätsklinikum Regensburg
Regensburg, 93053
Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, 42699
France1 site
Centre Hospitalier Universitaire Grenoble Alpes, Pole Thorax et Vaisseaux (PTV), Clinique de Physiologie Sommeil et Exercice
Grenoble, 38043
About this study
The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.
Read the detailed description
In this retrospective analysis the health care utilization in patients with COPD and HF will be quantified. Data of patients who additionally underwent a polysomnography or polygraphy between 2012 and 2015 are taken into consideration. The data (risk for hospitalization and death, comorbidities, diagnosis and therapy of SDB, costs of health care utilization) will be collected 12 months before and 12 months after diagnosis of SDB.
The patients' medical records will also be reviewed for compliance to treatment for SDB, and the patients will be classified as treated or untreated. The treated group will be divided into two subgroups: those with "good adherence" to PAP therapy (≥ 4 hours PAP use per night) and those with "poor adherence" to PAP therapy (< 4 hours PAP use per night). Healthcare Utilizations, HF or COPD exacerbations and mortality will be identified by reviewing medical records, National database when available, or self-reported by patient or patient's family through phone interview or questionnaire.
- Being tested
- polygraphy or polysomnography
- Medical subject headings
- Sleep Apnea Syndromes, Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polygraphy or polysomnographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SDB+COPD | Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease Receives: Procedure: polygraphy or polysomnography | |
| SDB+HF | Patients with sleep-disordered breathing and concomitant heart failure Receives: Procedure: polygraphy or polysomnography | |
| SDB+COPD+HF | Patients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease and heart failure Receives: Procedure: polygraphy or polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Healthcare Costs
Measured: 2 years
Diagnosis-related Healthcare Costs
Measured: 2 years
Adherence to PAP therapy, (% days with usage >=4h/night)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start16 May 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Respironics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923505
- Sponsor's protocol ID
- WI_COPD+HF+SDB_16-250
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)
- ClinicalTrials.gov ID
- NCT02923505
- Acronym / sponsor ID
- WI_COPD+HF+SDB_16-250
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Philips Respironics
- Study start
- 16 May 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 4 Oct 2016 (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.
The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.
Detailed description
In this retrospective analysis the health care utilization in patients with COPD and HF will be quantified. Data of patients who additionally underwent a polysomnography or polygraphy between 2012 and 2015 are taken into consideration. The data (risk for hospitalization and death, comorbidities, diagnosis and therapy of SDB, costs of health care utilization) will be collected 12 months before and 12 months after diagnosis of SDB.
The patients' medical records will also be reviewed for compliance to treatment for SDB, and the patients will be classified as treated or untreated. The treated group will be divided into two subgroups: those with "good adherence" to PAP therapy (≥ 4 hours PAP use per night) and those with "poor adherence" to PAP therapy (< 4 hours PAP use per night). Healthcare Utilizations, HF or COPD exacerbations and mortality will be identified by reviewing medical records, National database when available, or self-reported by patient or patient's family through phone interview or questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SDB+COPD | – | Procedure: polygraphy or polysomnographyPatients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease |
| SDB+HF | – | Procedure: polygraphy or polysomnographyPatients with sleep-disordered breathing and concomitant heart failure |
| SDB+COPD+HF | – | Procedure: polygraphy or polysomnographyPatients with sleep-disordered breathing and concomitant chronic obstructive pulmonary disease and heart failure |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient from primary care clinics and sleep medicine centers
Key inclusion criteria (3 listed)
- subjects between 21 to 75 years;
- consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/2015.
- diagnosis of COPD and/or HF
Key exclusion criteria (1 listed)
- age <21 or >75 years
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 |
|---|---|---|
| polygraphy or polysomnography | Procedure or surgery | SDB+COPD, SDB+COPD+HF, SDB+HF |
Primary outcome
All-cause Healthcare Costs
Time frame: 2 years
Diagnosis-related Healthcare Costs
Time frame: 2 years
Adherence to PAP therapy, (% days with usage >=4h/night)
Time frame: 2 years
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 29 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-Disordered Breathing and Pulmonary Disease, Chronic Obstructive, run by Wissenschaftliches Institut Bethanien e.V at 5 sites in 3 countries.
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 1 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Denmark, France. 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?
All-cause Healthcare Costs (time frame: 2 years). The study lists 3 primary outcomes in all. 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 29 Oct 2018.