Sleep Disorders in Idiopathic Pulmonary Fibrosis

NCT05113654 | Completed

• 1 other identifier: WI_SleepIPF_169/2015
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

IPF

Patients with idiopathic pulmonary fibrosis

Diagnostic Test: Sleep study

COPD

Patients with chronic obstructive pulmonary disease

Diagnostic Test: Sleep study

Healthy

Healthy controls

Diagnostic Test: Sleep study

Interventions

Sleep study DIAGNOSTIC_TEST

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

COPD; Healthy; IPF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants were recruited from clinical routine patients.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Winfried Randerath, Prof. Dr.

  Wissenschaftliches Institut Bethanien e.V

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 9, 2021
• Study Start: April 26, 2016
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)