Headache DisordersNLPH SPEECHNCT05204316
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients
A study testing Digital Analysis of Speech in people with Headache Disorders, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache Disorders
- What is being tested?
- Digital Analysis of Speech
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is a patient of the tertiary headache clinic at Ghent University Hospital
- is 18 years or older
- has Dutch as native speaking language
Who cannot join
- has difficulties in producing spoken language
- has limited or no knowledge of Dutch
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Headache Disorders
- Being tested
- Digital Analysis of Speech
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Analysis of SpeechOther
Recordings will be transcribed manually to written digital text formats, on which NLP tools such as tokenisation and lexical analysis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants will provide spoken narratives on their headache disorder Receives: Other: Digital Analysis of Speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linguistic analysis of texts
Descriptive linguistic analysis of lexical choices, sentence formation and thematic content within the texts
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
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
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start13 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204316
- Sponsor's protocol ID
- BC-10619
- Acronym
- NLPH SPEECH
- Status last verified
- May 2024
- First submitted
- 10 Jan 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Strict secured storage of IPD on Ghent University Hospital servers.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients
- ClinicalTrials.gov ID
- NCT05204316
- Acronym / sponsor ID
- NLPH SPEECH / BC-10619
- Conditions
- Headache Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Digital Analysis of SpeechParticipants will provide spoken narratives on their headache disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- is a patient of the tertiary headache clinic at Ghent University Hospital
- is 18 years or older
- has Dutch as native speaking language
Key exclusion criteria (2 listed)
- has difficulties in producing spoken language
- has limited or no knowledge of Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Analysis of SpeechRecordings will be transcribed manually to written digital text formats, on which NLP tools such as tokenisation and lexical analysis will be performed. | Other | Participants |
Primary outcome
Linguistic analysis of texts
Time frame: through study completion, an average of 1 year
Descriptive linguistic analysis of lexical choices, sentence formation and thematic content within the texts
2 secondary outcomes
Machine learning modelling for classification of headache disorders
Time frame: through study completion, an average of 1 year
Machine learning modelling for estimation of headache impact scores
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. Strict secured storage of IPD on Ghent University Hospital servers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Analysis of Speech in people with Headache Disorders, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linguistic analysis of texts (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.