Idiopathic Pulmonary FibrosisNCT05113654
Sleep Disorders in Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Sleep study
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2016to 7 Jun 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants were recruited from clinical routine patients.
Who may be able to join
- Age >=18 years
- 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)
Who cannot join
- Long-term oxygen therapy
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Wissenschaftliches Institut Bethanien e.V.
Solingen, North Rhine-Westphalia, 42699
About this study
This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Sleep study
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep studyDiagnostic test
Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders
| Study group | Role | What they receive |
|---|---|---|
| IPF | Patients with idiopathic pulmonary fibrosis Receives: Diagnostic Test: Sleep study | |
| COPD | Patients with chronic obstructive pulmonary disease Receives: Diagnostic Test: Sleep study | |
| Healthy | Healthy controls Receives: Diagnostic Test: Sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3)
Sleep disorders defined by the International Classfication of Sleep Disorders are diagnosed by a single sleep study (polysomnography or polygraphy), lasting between 5 and 9 hours for each individual participant. The number of patients for whom at least one sleep disorder is diagnosed, is used to calculate the prevalence of sleep disorders among each patient group.
Measured: For individual assessment of sleep disorders: one night (between 5 and 9 hours), for overall number of patients: entire study duration (37 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start26 Apr 2016
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Winfried Randerath, Prof. Dr., Principal investigator, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113654
- Sponsor's protocol ID
- WI_SleepIPF_169/2015
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 9 Nov 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 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05113654
- Acronym / sponsor ID
- WI_SleepIPF_169/2015
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 9 Nov 2021 (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.
This diagnostic observational study was conducted to (1) investigate the prevalence of sleep-related breathing disorders and other sleep disorders in idiopathic pulmonary fibrosis in comparison to COPD, (2) identify characteristics of symptomatic and prognostic significance in idiopathic pulmonary fibrosis with/without sleep disorders, and (3) evaluate different tools for their ability to assess the risk of co-existing sleep disorders in idiopathic pulmonary fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPF | – | Diagnostic Test: Sleep studyPatients with idiopathic pulmonary fibrosis |
| COPD | – | Diagnostic Test: Sleep studyPatients with chronic obstructive pulmonary disease |
| Healthy | – | Diagnostic Test: Sleep studyHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants were recruited from clinical routine patients.
Key inclusion criteria (4 listed)
- Age >=18 years
- 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)
Key exclusion criteria (12 listed)
- Long-term oxygen therapy
- 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)
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 studyNocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders | Diagnostic test | COPD, Healthy, IPF |
Primary outcome
Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3)
Time frame: For individual assessment of sleep disorders: one night (between 5 and 9 hours), for overall number of patients: entire study duration (37 months)
Sleep disorders defined by the International Classfication of Sleep Disorders are diagnosed by a single sleep study (polysomnography or polygraphy), lasting between 5 and 9 hours for each individual participant. The number of patients for whom at least one sleep disorder is diagnosed, is used to calculate the prevalence of sleep disorders among each patient group.
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 9 Nov 2021.
- 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.
Winfried Randerath, Prof. Dr. principal investigator
Wissenschaftliches Institut Bethanien e.V
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, 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 4 inclusion and 12 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 9 Nov 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?
Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3) (time frame: For individual assessment of sleep disorders: one night (between 5 and 9 hours), for overall number of patients: entire study duration (37 months)). 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 9 Nov 2021.