Sleep Disorders in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Sleep Disorders in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113654
• Other study ID #: WI_SleepIPF_169/2015
• Status: Completed
• Start date: April 26, 2016
• Est. completion date: June 7, 2019

Study information

• Verified date: October 2021
• Source: Wissenschaftliches Institut Bethanien e.V
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Parasomnias
• Pulmonary Fibrosis
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Sleep study
Nocturnal polysomnography or polygraphy to assess sleep-related breathing disorder and other sleep disorders

Locations

Country	Name	City	State
Germany	Wissenschaftliches Institut Bethanien e.V.	Solingen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Wissenschaftliches Institut Bethanien e.V	Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For individual assessment of sleep disorders: one night (between 5 and 9 hours), for overall number of patients: entire study duration (37 months)