Sleep Disorders in Idiopathic Pulmonary Fibrosis

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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
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

Treatment and study plan

sleep study

Diagnostic Test

Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

Boehringer Ingelheim

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Nov 9, 2021
Registry last updated: Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed