StrokeNCT07840703
Symptomatic Hyperventilation in Individuals Living With Stroke
An observational study of Stroke and Hyperventilation Syndrome, run by Istinye University.
Trial summary
This study will investigate the effects of hyperventilation syndrome on respiratory muscle strength, respiratory muscle endurance, pulmonary functions, and functional capacity in individuals living with stroke, and in this context, stroke patients with and without hyperventilation syndrome based on Nijmegen… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hyperventilation Syndrome
- What is being tested?
- Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2026to 15 Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise adult individuals diagnosed with stroke (ischaemic or haemorrhagic) who are in the post-stroke period. Participants will be recruited and screened based on the Nijmegen Questionnaire score to form two distinct cohorts: individuals presenting with symptomatic hyperventilation syndrome and individuals without hyperventilation syndrome.
Who may be able to join
- Individuals who will be diagnosed with a confirmed first-ever or recurrent stroke (ischaemic or haemorrhagic) verified by neuroimaging (CT or MRI).
- Individuals who will be in the chronic or subacute post-stroke period (medically stable following stroke onset).
- Individuals aged 18 years and older.
- Individuals who will be classified into either the hyperventilation syndrome group based on a Nijmegen Questionnaire score of ≥23 or the control group based on a score of <23.
- Individuals who will be able to comprehend instructions and cooperate adequately with pulmonary function tests, respiratory muscle testing, and physical performance assessments.
- Individuals who will provide written informed consent to participate in the study.
Who cannot join
- Individuals who will present with severe cognitive impairment, aphasia, or psychiatric disorders that will prevent reliable completion of questionnaires (such as the Nijmegen Questionnaire) or cooperation with test procedures.
- Individuals who will have pre-existing primary chronic obstructive pulmonary disease (COPD), asthma, restrictive thoracic diseases, or other major pre-existing pulmonary pathologies that will confound pulmonary function test results.
- Individuals who will have unstable cardiovascular conditions (e.g., recent myocardial infarction within the past 3-6 months, unstable angina pectoris, uncontrolled malignant arrhythmias, or uncontrolled severe hypertension) that will pose a risk during physical testing (such as the six-minute walk test).
- Individuals who will have severe orthopedic, musculoskeletal, or lower extremity peripheral disorders unrelated to stroke that will independently limit functional capacity and walking distance (6MWD).
- Individuals who will have active respiratory tract infections or acute pulmonary illnesses at the time of evaluation. Individuals who will be participating in an active pulmonary rehabilitation program or receiving respiratory muscle training concurrently.
About this study
Official title: Impact of Symptomatic Hyperventilation on Respiratory Parameters and Functional Capacity Among Individuals Living With Stroke: A Comparative Study
This study will investigate the effects of hyperventilation syndrome on respiratory muscle strength, respiratory muscle endurance, pulmonary functions, and functional capacity in individuals living with stroke, and in this context, stroke patients with and without hyperventilation syndrome based on Nijmegen Questionnaire scores will be compared to evaluate the relationship between symptom burden and respiratory parameters.
- Conditions
- Stroke, Hyperventilation Syndrome
- Being tested
- Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments
- Keywords
- Stroke, Hyperventilation syndrome, Respiratory muscle strength, Respiratory muscle endurance, Pulmonary function, Functional capacity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Function, Respiratory Muscle Strength, and Functional Capacity AssessmentsOther
Both groups will undergo comprehensive evaluations including pulmonary function tests (FEV1, FVC, PEF), respiratory muscle strength (PImax, PEmax), respiratory muscle endurance tests, the Nijmegen Questionnaire, and the six-minute walk test (6MWT) to assess functional capacity.
| Study group | Role | What they receive |
|---|---|---|
| Hyperventilation Syndrome Group | Not described Receives: Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments | |
| Without Hyperventilation Syndrome Group | Not described Receives: Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in One Second (FEV1 % predicted)
FEV1 percent predicted values will be measured to evaluate and compare pulmonary function between the hyperventilation syndrome group and the control group.
Measured: Measured at baseline/assessment
Maximal inspiratory pressure (PImax)
Maximal inspiratory pressure will be assessed to determine respiratory muscle strength.
Measured: Measured at baseline/assessment.
Secondary outcomes (5)
Maximal expiratory pressure (PEmax)
Maximal expiratory pressure will be assessed to determine respiratory muscle strength.
Measured: Measured at baseline/assessment.
Respiratory Muscle Endurance Score
Respiratory muscle endurance scores will be recorded to evaluate breathing endurance between groups.
Measured: Measured at baseline/assessment.
Forced Vital Capacity (FVC)
FVC percentage value will be analyzed to assess restrictive patterns and flow rates.
Measured: Measured at baseline/assessment.
Peak Expiratory Flow (PEF)
PEF value will be analyzed to assess restrictive patterns and flow rates.
Measured: Measured at baseline/assessment.
Six-Minute Walk Distance (6MWD)
The six-minute walk test will be performed to measure functional capacity distance in meters.
Measured: Measured at baseline/assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840703
- Sponsor's protocol ID
- 116
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Symptomatic Hyperventilation on Respiratory Parameters and Functional Capacity Among Individuals Living With Stroke: A Comparative Study
- ClinicalTrials.gov ID
- NCT07840703
- Acronym / sponsor ID
- 116
- Conditions
- Stroke, Hyperventilation Syndrome
- Keywords
- Stroke, Hyperventilation syndrome, Respiratory muscle strength, Respiratory muscle endurance, Pulmonary function, Functional capacity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Sep 2026 (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.
This study will investigate the effects of hyperventilation syndrome on respiratory muscle strength, respiratory muscle endurance, pulmonary functions, and functional capacity in individuals living with stroke, and in this context, stroke patients with and without hyperventilation syndrome based on Nijmegen Questionnaire scores will be compared to evaluate the relationship between symptom burden and respiratory parameters.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperventilation Syndrome Group | – | Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments |
| Without Hyperventilation Syndrome Group | – | Other: Respiratory Function, Respiratory Muscle Strength, and Functional Capacity Assessments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise adult individuals diagnosed with stroke (ischaemic or haemorrhagic) who are in the post-stroke period. Participants will be recruited and screened based on the Nijmegen Questionnaire score to form two distinct cohorts: individuals presenting with symptomatic hyperventilation syndrome and individuals without hyperventilation syndrome.
Key inclusion criteria (6 listed)
- Individuals who will be diagnosed with a confirmed first-ever or recurrent stroke (ischaemic or haemorrhagic) verified by neuroimaging (CT or MRI).
- Individuals who will be in the chronic or subacute post-stroke period (medically stable following stroke onset).
- Individuals aged 18 years and older.
- Individuals who will be classified into either the hyperventilation syndrome group based on a Nijmegen Questionnaire score of ≥23 or the control group based on a score of <23.
- Individuals who will be able to comprehend instructions and cooperate adequately with pulmonary function tests, respiratory muscle testing, and physical performance assessments.
Key exclusion criteria (5 listed)
- Individuals who will present with severe cognitive impairment, aphasia, or psychiatric disorders that will prevent reliable completion of questionnaires (such as the Nijmegen Questionnaire) or cooperation with test procedures.
- Individuals who will have pre-existing primary chronic obstructive pulmonary disease (COPD), asthma, restrictive thoracic diseases, or other major pre-existing pulmonary pathologies that will confound pulmonary function test results.
- Individuals who will have unstable cardiovascular conditions (e.g., recent myocardial infarction within the past 3-6 months, unstable angina pectoris, uncontrolled malignant arrhythmias, or uncontrolled severe hypertension) that will pose a risk during physical testing (such as the six-minute walk test).
- Individuals who will have severe orthopedic, musculoskeletal, or lower extremity peripheral disorders unrelated to stroke that will independently limit functional capacity and walking distance (6MWD).
- Individuals who will have active respiratory tract infections or acute pulmonary illnesses at the time of evaluation. Individuals who will be participating in an active pulmonary rehabilitation program or receiving respiratory muscle training concurrently.
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 |
|---|---|---|
| Respiratory Function, Respiratory Muscle Strength, and Functional Capacity AssessmentsBoth groups will undergo comprehensive evaluations including pulmonary function tests (FEV1, FVC, PEF), respiratory muscle strength (PImax, PEmax), respiratory muscle endurance tests, the Nijmegen Questionnaire, and the six-minute walk test (6MWT) to assess functional capacity. | Other | Hyperventilation Syndrome Group, Without Hyperventilation Syndrome Group |
Primary outcome
Change in Forced Expiratory Volume in One Second (FEV1 % predicted)
Time frame: Measured at baseline/assessment
FEV1 percent predicted values will be measured to evaluate and compare pulmonary function between the hyperventilation syndrome group and the control group.
Maximal inspiratory pressure (PImax)
Time frame: Measured at baseline/assessment.
Maximal inspiratory pressure will be assessed to determine respiratory muscle strength.
5 secondary outcomes
Maximal expiratory pressure (PEmax)
Time frame: Measured at baseline/assessment.
Respiratory Muscle Endurance Score
Time frame: Measured at baseline/assessment.
Forced Vital Capacity (FVC)
Time frame: Measured at baseline/assessment.
Peak Expiratory Flow (PEF)
Time frame: Measured at baseline/assessment.
Six-Minute Walk Distance (6MWD)
Time frame: Measured at baseline/assessment.
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 25 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hyperventilation Syndrome, run by Istinye University.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Forced Expiratory Volume in One Second (FEV1 % predicted) (time frame: Measured at baseline/assessment). The study lists 2 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 25 Sep 2026.