Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
78 participants
OBSERVATIONAL
2016-04-26
2019-06-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IPF
Patients with idiopathic pulmonary fibrosis
Sleep study
Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders
COPD
Patients with chronic obstructive pulmonary disease
Sleep study
Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders
Healthy
Healthy controls
Sleep study
Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sleep study
Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* written informed consent
* IPF cohort: Documented history of IPF with definite or possible UIP pattern and signs of emphysema below 10% by HRCT (IPF diagnosis according to 2011 ATS/ERS IPF guidelines)
* COPD cohort: Documented history of COPD Stage II Group A or B, Stage III or IV, Group C or D (GOLD 2014)
Exclusion Criteria
* Heart failure NYHA stages III and IV
* Left ventricular ejection fraction ≤ 45%
* Pregnancy and/or lactation
* Acute and/or life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, malignant tumor requiring treatment)
* Current drug or alcohol abuse
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent
* IPF cohort: Acute exacerbation of IPF
* IPF cohort: Concomitant lung/airway diseases other than IPF (signs of emphysema \>10% by HRCT)
* COPD cohort: Acute exacerbation of COPD
* COPD cohort: Concomitant lung/airway diseases other than COPD (e.g. Asthma bronchiale)
* Healthy cohort: Documented history of structural airway or lung disease
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Wissenschaftliches Institut Bethanien e.V
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Winfried Randerath, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Wissenschaftliches Institut Bethanien e.V
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wissenschaftliches Institut Bethanien e.V.
Solingen, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WI_SleepIPF_169/2015
Identifier Type: -
Identifier Source: org_study_id