Phenotype of Headache and Facial Pain in Upper Respirator... | NCT06127186

Studies
Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections

NCT06127186

Sponsor

Marcin Straburzynski

Status

Completed

Last Update Posted

Apr 9, 2024Actual

Enrollment

223Actual

Phase

Not provided

Conditions

Upper Respiratory Tract Infections

Interventions

Swab test for viral antigens

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Mar 31, 2024Actual

Completion Date

Mar 31, 2024Actual

First Submitted Date

Nov 4, 2023

First Submission Date that Met QC Criteria

Nov 9, 2023

First Posted Date

Nov 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (URTI). The main question it aims to answer are:

What is the phenotype of headache / facial pain in URTIs
Does the above mentioned phenotype is associated with:
1. aetiologic factor (virus),
2. type of URTI
3. headache/facial pain experienced by patients in the past.

Participants will:

answer standardized questions,
undergo physical examination,
have a swab test performend for antigens of common viruses causing URTI.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

223Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Patients reporting for primary care assessment because of URTI.	Diagnostic Test: Swab test for viral antigens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Swab test for viral antigens	Diagnostic Test	No intervention except for a routine examination and viral testing is planned.	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with one of the specified pain phenotypes	Percentage of patients with one of the specified pain phenotypes (migraine-like/tension-type-like/trigeminal cephalalgia-like)	A single assessment during primary care physician office 1 day visit.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

URTI confirmed by primary care physician
Informed consent to participate in the study

Exclusion Criteria:

chronic or recurrent upper respiratory tract disorders
neoplasms
signs or symptoms of a serious neurologic or psychiatric disorder.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients with upper respiratory tract infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marcin Straburzyński		Dźwierzuty	Warmian-Masurian Voivodeship	12-120	Poland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized data will be made available in a public repository after study completion.

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012141	Respiratory Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010808	Physical Examination

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided