Thoracic Outlet SyndromeNCT06992752
Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome
An observational study of Thoracic Outlet Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study was to learn about the characteristics of dysfunctional breathing in individuals with thoracic outlet syndrome. The main question to be answered is: Is there a dysfunctional breathing pattern in individuals with Thoracic outlet syndrome? These features will be compared with a… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Outlet Syndrome
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2025to 2 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In the study, adult patients aged between 18-65 years who were diagnosed with TOS by a thoracic surgeon at the Cardiopulmonary Rehabilitation Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, and who had pain complaints for more than 6 months without surgery will be evaluated. Control cases planned to be included in the study to compare with the results of the patients will be formed by using the snowball method from the immediate environment.
Who may be able to join
- To agree to participate in the study,
- To have been diagnosed with TOS by a thoracic surgeon,
- To be between 18-65 years old,
- Having pain for more than 6 months
Who cannot join
- Patients with a history of spinal or thoracic surgery for TOS or any other reason,
- People with traumatic cervical injury,
- Severely obese people (BMI >40 kg/m2),
- People with clinical abnormalities in the thoracic cage or vertebral column,
- Persons with occupational industrial exposures,
- Patients with severe comorbidities (neurological, neuromuscular, -cardiorespiratory, psychiatric and musculoskeletal) diabetes mellitus and/or malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Altındağ, 06100
Melda Sağlam, Professor, +903123052525 ext. 146, msaglam@hacettepe.edu.tr
Ebru Çalık Kütükcü, Professor, +903122525 ext. 195, ebrucalik@hacettepe.edu.tr
About this study
Official title: Investigation of the Properties of Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome
The aim of this observational study was to learn about the characteristics of dysfunctional breathing in individuals with thoracic outlet syndrome. The main question to be answered is:
Is there a dysfunctional breathing pattern in individuals with Thoracic outlet syndrome? These features will be compared with a healthy control group to evaluate the association of Thoracic outlet syndrome with dysfunctional breathing
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Thoracic Outlet Syndrome, Dysfunctional Breathing
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Outlet Syndrome | Thoracic Outlet Syndrome | |
| Healthy control | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nijmegen Questionnaire
A cut-off score of ≥20 in Nijmegen will be used to define dysfunctional breathing. The minimum score is 0 and the maximum score is 60 points. Higher scores mean worse outcome.
Measured: Day 1
End tidal CO2
A standard value of <35 mmHg will be used as the cut-off point for dysfunction
Measured: Day 1
Manual Assessment of Respiratory Motion
This technique is used to assess and measure the distribution of respiratory movement between the upper and lower parts of the rib cage and abdomen
Measured: 5 minutes
Secondary outcomes (13)
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) will be done with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The total amount of air (L) that can be forced out after taking a deep breath will be recorded. Measures lung capacity.
Measured: Day 1
Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second (FEV1) will be done with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The amount of air (L) a person can forcefully expel in the first second of a breath will be recorded
Measured: Day 1
FEV1/FVC Ratio
The percentage of the ratio of FEV1 to FVC will be calculated and recorded
Measured: Day 1
Forced Expiratory Flow 25-75% (FEF25-75)
Forced Expiratory Flow 25-75% (FEF25-75%) will be assessed with a spirometer according to American Thoracic Society and European Respiratory Society criteria. The air flow rate (L/s) during the middle part of the exhalation (25%-75%) will be recorded.
Measured: Day 1
Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) will be assessed with a spirometer according to American Thoracic Society and European Respiratory Society criteria. The highest flow rate (L/s) achieved during a forceful exhalation will be recorded.
Measured: Day 1
Breath Holding at Functional Residual Capasity
If the duration is less than 25 seconds, it is considered as possible dysfunctional breathing
Measured: 5 minutes
Breath Holding at Total Lung Capacity
If the duration is less than 35 seconds, it is considered as possible dysfunctional breathing
Measured: 5 minutes
Pain severity
Visual analog scale (VAS) will be used in the assessment.Individuals' pain at rest, during activity and at night will be assessed on a scale of 0-10.Minimum score is 0 and maximum score is 10 Higher scores mean a worse outcome.
Measured: 5 minutes
Pain treshold
For the assessment of pain threshold, the minimum pressure value that causes pain or discomfort will be recorded
Measured: 10 minutes
Pain tolerance
the maximum tolerated pressure value will be recorded in the assessment of pain tolerance
Measured: 10 minutes
Beck Anxiety Scale
The scale has 21 questions. The questions will be answered by selecting one of four options: none, mild, moderate and severe. 8-15 points will be categorized as mild anxiety symptoms, 16-25 points as moderate anxiety symptoms, 26 - 63 points as severe anxiety symptoms. the maximum score of the scale is 63
Measured: 5 minutes
EQ-5D-5L General Quality of Life Scale
The scale has two parts. The first section has five sub-scales: movement, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given in each section have 5 options; "no problem", "mild problem", "moderate problem", "severe problem" and "extreme problem". In the second section, individuals give a value between 0 and 100 about their current health status.
Measured: 5 minutes
Type D Personality Scale
It consists of a total of 14 items and two subscales measuring negative affectivity and social inhibition. Each item is scored on a 0-4 scale. The cut-off point of the two subscales is ≥ 10.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start2 Feb 2025
- Primary completion2 Sep 2025 (estimated)
- Study completion2 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melda Saglam, Hacettepe University
- Investigators
- Melda Sağlam, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992752
- Sponsor's protocol ID
- SBA-24/775
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for patient data privacy
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Properties of Dysfunctional Breathing in Individuals With Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT06992752
- Acronym / sponsor ID
- SBA-24/775
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Thoracic Outlet Syndrome, Dysfunctional Breathing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 2 Oct 2025 (estimated)
- First posted
- 28 May 2025 (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 aim of this observational study was to learn about the characteristics of dysfunctional breathing in individuals with thoracic outlet syndrome. The main question to be answered is:
Is there a dysfunctional breathing pattern in individuals with Thoracic outlet syndrome? These features will be compared with a healthy control group to evaluate the association of Thoracic outlet syndrome with dysfunctional breathing
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Outlet Syndrome | – | –Thoracic Outlet Syndrome |
| Healthy control | – | –Healthy control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In the study, adult patients aged between 18-65 years who were diagnosed with TOS by a thoracic surgeon at the Cardiopulmonary Rehabilitation Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, and who had pain complaints for more than 6 months without surgery will be evaluated. Control cases planned to be included in the study to compare with the results of the patients will be formed by using the snowball method from the immediate environment.
Key inclusion criteria (4 listed)
- To agree to participate in the study,
- To have been diagnosed with TOS by a thoracic surgeon,
- To be between 18-65 years old,
- Having pain for more than 6 months
Key exclusion criteria (6 listed)
- Patients with a history of spinal or thoracic surgery for TOS or any other reason,
- People with traumatic cervical injury,
- Severely obese people (BMI >40 kg/m2),
- People with clinical abnormalities in the thoracic cage or vertebral column,
- Persons with occupational industrial exposures,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nijmegen Questionnaire
Time frame: Day 1
A cut-off score of ≥20 in Nijmegen will be used to define dysfunctional breathing. The minimum score is 0 and the maximum score is 60 points. Higher scores mean worse outcome.
End tidal CO2
Time frame: Day 1
A standard value of <35 mmHg will be used as the cut-off point for dysfunction
Manual Assessment of Respiratory Motion
Time frame: 5 minutes
This technique is used to assess and measure the distribution of respiratory movement between the upper and lower parts of the rib cage and abdomen
13 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Day 1
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Day 1
FEV1/FVC Ratio
Time frame: Day 1
Forced Expiratory Flow 25-75% (FEF25-75)
Time frame: Day 1
Peak Expiratory Flow (PEF)
Time frame: Day 1
Breath Holding at Functional Residual Capasity
Time frame: 5 minutes
Breath Holding at Total Lung Capacity
Time frame: 5 minutes
Pain severity
Time frame: 5 minutes
Pain treshold
Time frame: 10 minutes
Pain tolerance
Time frame: 10 minutes
Beck Anxiety Scale
Time frame: 5 minutes
EQ-5D-5L General Quality of Life Scale
Time frame: 5 minutes
Type D Personality Scale
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No. for patient data privacy
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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.
Melda Sağlam, Professor principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Outlet Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melda Sağlam, Professor (+903123052525 ext. 146, msaglam@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nijmegen Questionnaire (time frame: Day 1). The study lists 3 primary outcomes in all. 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 28 May 2025.