- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791451
Predicting Exacerbation of COPD With Wireless Telemonitoring
April 12, 2021 updated by: Turku University Hospital
Open-Label Prospective Study of Predicting Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) With Wireless Telemonitoring of Respiratory Rate, Heart Rate and Sleep
This is an open-label single-center 6-month prospective clinical trial predicting exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep in patients admitted to the pulmonary ward of the Turku University Hospital due to acute exacerbation of COPD.
Study Overview
Detailed Description
A bed sensor based on ballistocardiogram (BCG) will be used to wireless telemonitoring of respiratory rate, heart rate and sleep for six months after an acute exacerbation of COPD.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive patients treated due to acute exacerbation of COPD at the pulmonary wards of the Turku University Hospital
Exclusion Criteria:
- Those sleeping with a bed partner and not having separate mattresses
- Patients with pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemonitoring
Exacerbation of COPD with wireless telemonitoring of respiratory rate, heart rate and sleep.
|
To predict exacerbation of COPD with wireless telemonitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time window to detect acute exacerbation of COPD
Time Frame: Six months
|
Time window to detect acute exacerbation of COPD
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
June 1, 2016
First Submitted That Met QC Criteria
June 1, 2016
First Posted (Estimate)
June 6, 2016
Study Record Updates
Last Update Posted (Actual)
April 15, 2021
Last Update Submitted That Met QC Criteria
April 12, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- COPD_BCG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.