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Sleep Disorders in Idiopathic Pulmonary Fibrosis

W

Wissenschaftliches Institut Bethanien e.V

Status

Completed

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Diagnostic Test: Sleep study

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05113654
WI_SleepIPF_169/2015

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

78 participants in 3 patient groups

IPF
Description:
Patients with idiopathic pulmonary fibrosis
Treatment:
Diagnostic Test: Sleep study
COPD
Description:
Patients with chronic obstructive pulmonary disease
Treatment:
Diagnostic Test: Sleep study
Healthy
Description:
Healthy controls
Treatment:
Diagnostic Test: Sleep study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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