Healthy ParticipantsNCT07755332
Association Between Central Sensitization and the Root Mean Square of Successive Differences
An observational study of Healthy Participants, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the relationship between central sensitization and resting RMSSD (Root Mean Square of Successive Differences) in individuals exhibiting prolonged sitting behavior, controlling for potential confounding factors such as age, gender, and body mass index; and to evaluate whether… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Apr 2026
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of healthy young adults aged 18-45 years who spent at least 30 hours sitting per week.
Who may be able to join
- Age range: Between 18 and 45 years of age.
- Sitting time: Having at least 30 hours of sitting time per week.
- Voluntary participation: Voluntarily agreeing to participate in the study.
- Cognitive and sensory capacity: Having the cognitive, auditory, and visual capacity to understand the study procedures and perform the tasks.
- Physical fitness: Not having any physical condition that would prevent the use of the HRV measuring device.
Who cannot join
- Having any cardiovascular, neurological, or systemic disease that interferes with physical activity,
- Using medications that may affect the autonomic nervous system within the last month,
- Having a history of cognitive impairment,
- Having engaged in strenuous exercise or had a febrile illness within the last 24 hours,
- Having a clinically diagnosed central sensitization syndrome,
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Demiroglu Bilim University
Istanbul, Istanbul, 34570
About this study
Official title: Association Between Central Sensitization and the Root Mean Square of Successive Differences in Individuals With Prolonged Sitting Behavior: A Cross-Sectional Study
The aim of this study was to examine the relationship between central sensitization and resting RMSSD (Root Mean Square of Successive Differences) in individuals exhibiting prolonged sitting behavior, controlling for potential confounding factors such as age, gender, and body mass index; and to evaluate whether participants, grouped according to sitting durations, differed in terms of RMSSD, central sensitization, balance, and executive cognitive function.
Read the detailed description
A sedentary lifestyle is becoming increasingly prevalent throughout society. Particularly in populations associated with prolonged sitting, while the cause of chronic pain is often attributed to mechanical factors, it is emphasized that central sensitization also plays a significant role in the pathophysiology of chronic pain. Given the multifaceted effects of central sensitization, heart rate variability (HRV)-a marker of balance, executive function, and autonomic function-gains importance. This study examined the relationship between participants' dynamic balance, Root Mean Square of Successive Differences (RMSSD)-one of the measurement parameters related to HRV-cognitive executive function, and central sensitization assessments. The findings are intended to shed light on clinical assessment and ergonomic intervention strategies for desk-based workers.
- Conditions
- Healthy Participants
- Being tested
- No intervention
- Keywords
- postural balance, executive function, central sensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Individuals who were between the ages of 18-45, had at least 30 hours of sitting time per week, agreed to participate voluntarily, and met the inclusion criteria participated. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Collection
Demographic information of the participants was collected using a participant assessment form developed by the research team. The form collected information about age, height, weight, body mass index, gender, education level, and weekly sitting time.
Measured: Baseline (Single Assessment)
Assessment of Central Sensitization
Central sensitivity was assessed using the Central Sensitivity Inventory. The scale ranges from 0 to 100, with higher scores indicating more severe symptoms.
Measured: Baseline (Single Assessment)
Assessment of Heart Rate Variability
Heart rate variability measurements were recorded at rest for 5 minutes using a Polar H10 device, in accordance with the recommendations of the European Society of Cardiology. The device was secured to the lower sternal notch with a belt. The RMSSD (Root Mean Square of Successive Differences, ms) parameter was used as an indicator of vagal activity.
Measured: Baseline (Single Assessment)
Secondary outcomes (2)
Assessment of Balance
The Y Balance Test was used in the balance assessment. First, leg length was determined. Participants were asked to reach as far as possible in the anterior, posteromedial, and posterolateral directions with their other foot, while keeping their test foot at the center point. The reach distances were normalized using the formula [(Best reach distance / Leg length) × 100], and the composite balance score was calculated by averaging the results from all three directions.
Measured: Baseline (Single Assessment)
Assessment of cognitive/executive function
The Verbal Fluency Test was used to assess cognitive/executive function. To measure semantic fluency, the category of animals was used, and the individual was asked to name animals for one minute. For phonemic fluency assessment, the letters 'k, a, s' were selected, and the words spoken using these letters were noted. When calculating the number of correct words, 1 point was given for each word produced according to the instructions.
Measured: Baseline (Single Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Akıl Ağdere, Istanbul Demiroglu Bilim University
- Investigators
- Selin Akil Agdere, Asst. Prof., Study director, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755332
- Sponsor's protocol ID
- 2025-07-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality agreements and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Central Sensitization and the Root Mean Square of Successive Differences in Individuals With Prolonged Sitting Behavior: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07755332
- Acronym / sponsor ID
- 2025-07-01
- Conditions
- Healthy Participants
- Keywords
- postural balance, executive function, central sensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 10 Aug 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.
The aim of this study was to examine the relationship between central sensitization and resting RMSSD (Root Mean Square of Successive Differences) in individuals exhibiting prolonged sitting behavior, controlling for potential confounding factors such as age, gender, and body mass index; and to evaluate whether participants, grouped according to sitting durations, differed in terms of RMSSD, central sensitization, balance, and executive cognitive function.
Detailed description
A sedentary lifestyle is becoming increasingly prevalent throughout society. Particularly in populations associated with prolonged sitting, while the cause of chronic pain is often attributed to mechanical factors, it is emphasized that central sensitization also plays a significant role in the pathophysiology of chronic pain. Given the multifaceted effects of central sensitization, heart rate variability (HRV)-a marker of balance, executive function, and autonomic function-gains importance. This study examined the relationship between participants' dynamic balance, Root Mean Square of Successive Differences (RMSSD)-one of the measurement parameters related to HRV-cognitive executive function, and central sensitization assessments. The findings are intended to shed light on clinical assessment and ergonomic intervention strategies for desk-based workers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Other: No interventionIndividuals who were between the ages of 18-45, had at least 30 hours of sitting time per week, agreed to participate voluntarily, and met the inclusion criteria participated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of healthy young adults aged 18-45 years who spent at least 30 hours sitting per week.
Key inclusion criteria (5 listed)
- Age range: Between 18 and 45 years of age.
- Sitting time: Having at least 30 hours of sitting time per week.
- Voluntary participation: Voluntarily agreeing to participate in the study.
- Cognitive and sensory capacity: Having the cognitive, auditory, and visual capacity to understand the study procedures and perform the tasks.
- Physical fitness: Not having any physical condition that would prevent the use of the HRV measuring device.
Key exclusion criteria (6 listed)
- Having any cardiovascular, neurological, or systemic disease that interferes with physical activity,
- Using medications that may affect the autonomic nervous system within the last month,
- Having a history of cognitive impairment,
- Having engaged in strenuous exercise or had a febrile illness within the last 24 hours,
- Having a clinically diagnosed central sensitization syndrome,
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 |
|---|---|---|
| No interventionNo intervention | Other | Healthy participants |
Primary outcome
Demographic Information Collection
Time frame: Baseline (Single Assessment)
Demographic information of the participants was collected using a participant assessment form developed by the research team. The form collected information about age, height, weight, body mass index, gender, education level, and weekly sitting time.
Assessment of Central Sensitization
Time frame: Baseline (Single Assessment)
Central sensitivity was assessed using the Central Sensitivity Inventory. The scale ranges from 0 to 100, with higher scores indicating more severe symptoms.
Assessment of Heart Rate Variability
Time frame: Baseline (Single Assessment)
Heart rate variability measurements were recorded at rest for 5 minutes using a Polar H10 device, in accordance with the recommendations of the European Society of Cardiology. The device was secured to the lower sternal notch with a belt. The RMSSD (Root Mean Square of Successive Differences, ms) parameter was used as an indicator of vagal activity.
2 secondary outcomes
Assessment of Balance
Time frame: Baseline (Single Assessment)
Assessment of cognitive/executive function
Time frame: Baseline (Single Assessment)
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 11 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality agreements and ethical restrictions.
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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.
Selin Akil Agdere, Asst. Prof. study director
Istanbul Demiroglu Bilim 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 Healthy Participants, run by Istanbul Demiroglu Bilim 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 5 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: finished, as of the sponsor's last update on 11 Aug 2026. 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?
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?
Demographic Information Collection (time frame: Baseline (Single Assessment)). 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 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.