Clincosm LogoSign in Get a demo

Sleep Disorders in Idiopathic Pulmonary Fibrosis

Sponsor
Wissenschaftliches Institut Bethanien e.V (Other)
Overall Status
Completed
CT.gov ID
NCT05113654
Collaborator
Boehringer Ingelheim (Industry)
78
Enrollment
1
Location
37.4
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sleep study

Study Design

Study Type:
Observational
Actual Enrollment :
78 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Sleep Disorders in Idiopathic Pulmonary Fibrosis
Actual Study Start Date :
Apr 26, 2016
Actual Primary Completion Date :
Jun 7, 2019
Actual Study Completion Date :
Jun 7, 2019

Arms and Interventions

Arm Intervention/Treatment
IPF

Patients with idiopathic pulmonary fibrosis

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

Patients with chronic obstructive pulmonary disease

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

Healthy controls

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with any kind of sleep disorder according to the International Classification of Sleep Disorders (ICSD-3) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wissenschaftliches Institut Bethanien e.V. Solingen NRW Germany 42699

Sponsors and Collaborators

  • Wissenschaftliches Institut Bethanien e.V
  • Boehringer Ingelheim

Investigators

  • Principal Investigator: Winfried Randerath, Prof. Dr., Wissenschaftliches Institut Bethanien e.V

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT05113654
Other Study ID Numbers:
  • WI_SleepIPF_169/2015
First Posted:
Nov 9, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Sleep Wake Disorders
Parasomnias
Fibrosis

Study Results

No Results Posted as of Nov 9, 2021