NCT05204316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

January 13, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

January 10, 2022

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Linguistic analysis of texts

    Descriptive linguistic analysis of lexical choices, sentence formation and thematic content within the texts

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Machine learning modelling for classification of headache disorders

    through study completion, an average of 1 year

  • Machine learning modelling for estimation of headache impact scores

    through study completion, an average of 1 year

Study Arms (1)

Participants

EXPERIMENTAL

Participants will provide spoken narratives on their headache disorder

Other: Digital Analysis of Speech

Interventions

Recordings will be transcribed manually to written digital text formats, on which NLP tools such as tokenisation and lexical analysis will be performed.

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • is a patient of the tertiary headache clinic at Ghent University Hospital
  • is 18 years or older
  • has Dutch as native speaking language

You may not qualify if:

  • has difficulties in producing spoken language
  • has limited or no knowledge of Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gent - Dienst Neurologie

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

January 13, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Strict secured storage of IPD on Ghent University Hospital servers.

Locations