Back to resultsNLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients (NLPH SPEECH)
Primary Purpose
Headache Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Digital Analysis of Speech
Sponsored by
About this trial
This is an interventional other trial for Headache Disorders
Eligibility Criteria
Inclusion Criteria:
- is a patient of the tertiary headache clinic at Ghent University Hospital
- is 18 years or older
- has Dutch as native speaking language
Exclusion Criteria:
- has difficulties in producing spoken language
- has limited or no knowledge of Dutch
Sites / Locations
- UZ Gent - Dienst Neurologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants
Arm Description
Participants will provide spoken narratives on their headache disorder
Outcomes
Primary Outcome Measures
Linguistic analysis of texts
Descriptive linguistic analysis of lexical choices, sentence formation and thematic content within the texts
Secondary Outcome Measures
Machine learning modelling for classification of headache disorders
To investigate the potential and learn insights of machine learning modelling to classify headache disorders based on the descriptions by participants
Machine learning modelling for estimation of headache impact scores
To investigate the potential and learn insights of machine learning modelling to estimate headache impact scores from different validated questionnaires investigating burden of disease and quality of life
Full Information
NCT ID
NCT05204316
First Posted
January 10, 2022
Last Updated
May 2, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05204316
Brief Title
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients
Acronym
NLPH SPEECH
Official Title
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The research collects spoken descriptions of headache disorders by participants with headache disorders. The speech recordings are analyzed by natural language processing (NLP) tools to analyse linguistic properties of the texts and to obtain insight into the potential of NLP machine learning models for the recognition of headache syndromes of the participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Experimental
Arm Description
Participants will provide spoken narratives on their headache disorder
Intervention Type
Other
Intervention Name(s)
Digital Analysis of Speech
Intervention Description
Recordings will be transcribed manually to written digital text formats, on which NLP tools such as tokenisation and lexical analysis will be performed.
Primary Outcome Measure Information:
Title
Linguistic analysis of texts
Description
Descriptive linguistic analysis of lexical choices, sentence formation and thematic content within the texts
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Machine learning modelling for classification of headache disorders
Description
To investigate the potential and learn insights of machine learning modelling to classify headache disorders based on the descriptions by participants
Time Frame
through study completion, an average of 1 year
Title
Machine learning modelling for estimation of headache impact scores
Description
To investigate the potential and learn insights of machine learning modelling to estimate headache impact scores from different validated questionnaires investigating burden of disease and quality of life
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
is a patient of the tertiary headache clinic at Ghent University Hospital
is 18 years or older
has Dutch as native speaking language
Exclusion Criteria:
has difficulties in producing spoken language
has limited or no knowledge of Dutch
Facility Information:
Facility Name
UZ Gent - Dienst Neurologie
City
Gent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Strict secured storage of IPD on Ghent University Hospital servers.
Learn more about this trial
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients
We'll reach out to this number within 24 hrs