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Heart Rate Variability and Nocturnal Blood Oxygen Saturation in Patients With Idiopathic Pulmonary Fibrosis

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT06027372
Collaborator
(none)
70
Enrollment
1
Location
49.3
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to compare the overnight heart rate variability (HRV) and nocturnal oxygen saturation (SpO2) in patients with idiopathic pulmonary fibrosis (IPF). The main questions it aims to answer are: (1). if there are correlations between pulmonary function test and HRV and overnight SpO2; (2). if HRV and SpO2 can predict the occurrence of acute exacerbation in patients with IPF. Participants will be asked to examine pulmonary function test (including lung volumes and six-minute walk test) and wear pulse oxygenation recorder and "LARGAN" ECG Holter" ("LARGAN HEALTH TECHNOLOGY" Sleep Apnea And Sleep Quality Examination System) during sleep.

Condition or Disease Intervention/Treatment Phase
  • Device: "LARGAN" ECG Holter

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Differences in Heart Rate Variability and Nocturnal Blood Oxygen Saturation of Patients With Idiopathic Pulmonary Fibrosis Between at Baseline and During Acute Exacerbation
Actual Study Start Date :
May 21, 2020
Anticipated Primary Completion Date :
Aug 27, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
IPF patients with acute exacerbation during test period

IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter reqire hospitalization during test period.

Device: "LARGAN" ECG Holter
wear "LARGAN" ECG Holter during sleep once after completion of pulmonary function test
IPF patients without acute exacerbation during test period

IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter remain stable during test period.

Device: "LARGAN" ECG Holter
wear "LARGAN" ECG Holter during sleep once after completion of pulmonary function test

Outcome Measures

Primary Outcome Measures

  1. The correlations between measures of pulmonary function test and heart rate variability [1 day test duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • individuals meet the diagnosis of idiopathic pulmonary fibrosis

  • individuals agree to participate this study and sign the informed consent

  • individuals have cognitive and behavioral abilities

Exclusion Criteria:

  • age less than 50 years old

  • individuals refuse to participate this study and sign the informed consent

  • individuals of unclear consciousness

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Veterans General Hospital Taipei Taiwan

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Director: Diahn-Warng Perng, PhD, Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT06027372
Other Study ID Numbers:
  • 2020-04-016BC
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Fibrosis

Study Results

No Results Posted as of Sep 7, 2023