Headache DisorderNCT06603493
Headaches: Effects on Sleep, Sensitization, and Psychological Factors
An observational study of Headache Disorder, run by Nagihan Acet at 1 site in Turkey (Türkiye).
Trial summary
Headache is one of the most common health problems in the society and negatively affects the quality of life of individuals. Increasing complaints of headache in recent years can be associated with many physiological and psychological factors. Sleep disturbances are one of these factors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorder
- What is being tested?
- Assessment of sleep disorders, Assessment of Central Sensitization and Assessment of depression, anxiety and stress levels
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2024to 19 Dec 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 18-65 with and without headaches.
Who may be able to join
- being 18-65 years who agreed to participate
Who cannot join
- Neurological disorders
- Musculoskeletal diseases
- Chronic pain conditions
- Psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Silent Saboteur: The Impact of Headaches on Sleep Disorders, Central Sensitization, Depression, Anxiety and Stress
Headache is one of the most common health problems in the society and negatively affects the quality of life of individuals. Increasing complaints of headache in recent years can be associated with many physiological and psychological factors. Sleep disturbances are one of these factors. Inadequate or non-restful sleep can interfere with the normal course of physical, mental, social and emotional functions. Impaired sleep quality interferes with the body\'s process of repairing and regenerating itself, which can lead to more serious health problems in the long term. Secondly, headaches can also lead to neurophysiological changes such as central sensitization. Central sensitization causes the nervous system to become hypersensitive, lowering the pain threshold and increasing pain perception. Finally, headache can have psychological effects by increasing levels of depression, anxiety and stress.
This study aimed to determine the effects of headache on sleep disturbances, central sensitization, depression, anxiety and stress.
Read the detailed description
Headache is one of the most common health problems in the society and types of headache have a significant negative impact on the quality of life of individuals. Headaches can occur in a wide range from temporary discomfort to chronic problems and can negatively affect individuals\' work performance, social life and general health . In recent years, complaints of headache have been increasing in the society. This may be associated with factors such as stress factors of modern life, sleep irregularities and increased use of technology.
One of the factors most affected by headache is sleep disturbance. Especially the presence of migraine can lead to sleep disorders. Sleep disorders consist of various conditions that disrupt normal sleep patterns and are one of the most common problems encountered in clinical practice. Inadequate or non-restful sleep may interfere with the normal course of physical, mental, social and emotional functions. Impaired sleep quality inhibits the body\'s process of self-repair and regeneration, which can lead to more serious health problems in the long term.
Establishing the relationship between sleep and headache can make a significant contribution to the management of headache.
Headaches can also be an important trigger of central sensitization. Central sensitization is an adaptive, activity-dependent and dynamic neurophysiological phenomenon]. This process involves neurobiological changes in neurons in the dorsal horn of the spinal cord.]. These changes include increased excitability, enhanced synaptic transmission and decreased inhibition. In summary, central sensitization is a condition in which the nervous system becomes hypersensitive and pain is perceived as more severe than normal. Especially in individuals with chronic headache, central sensitization may develop as a result of continuous stimulation of the nervous system and this may lead to a decrease in pain threshold and an increase in pain perception. Especially the fact that chronic headache triggers central sensitization is a factor that makes the treatment process very difficult and this situation seriously affects the quality of life of patients.
The psychological effects of headache cannot be ignored. Headache can increase depression, anxiety and stress levels. When pain becomes a constant source of anxiety, it makes it difficult to perform daily activities and negatively affects the general mood of the person. Depression and anxiety can increase the severity of headaches, and headaches can trigger these psychological conditions. Stress can be both a cause and a consequence of headache; especially tension-type headaches are closely related to stress. Therefore, it is important to consider the psychological status in the treatment of headache.
The presence of headache may affect many factors such as sleep disturbance, central sensitization, depression, anxiety and stress, and revealing these effects will contribute to the development of treatment approaches in headache treatment.
In the light of the above information, the aim of the present study was to determine the effect of the presence of headache on sleep disorders, central sensitization, depression, anxiety and stress.
- Conditions
- Headache Disorder
- Being tested
- Assessment of sleep disorders, Assessment of Central Sensitization, Assessment of depression, anxiety and stress levels
- Keywords
- Headache, sleep, Central Nervous System Sensitization, Depression, Anxiety, Pain
- Medical subject headings
- Headache Disorders, Headache, Depression, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sleep disordersOther
: Sleep disturbances will be assessed with the Pittsburgh Sleep Quality Index
Assessment of Central SensitizationOther
Central sensitization will be assessed with the Central Sensitization Inventory
Assessment of depression, anxiety and stress levelsOther
Depression, anxiety and stress levels will be assessed using the Depression, Anxiety, Stress Scale (DASS-21)
| Study group | Role | What they receive |
|---|---|---|
| Headache Group | individuals diagnosed with migraine and tension-type headache according to the International Classification of Headache Disorders (International Classification of Headache Disorders, 3rd edition) will be placed in the headache group Receives: Other: Assessment of sleep disorders; Other: Assessment of Central Sensitization; Other: Assessment of depression, anxiety and stress levels | |
| Control Group | Individuals aged 18-65 without headaches will be placed in control group. Receives: Other: Assessment of sleep disorders; Other: Assessment of Central Sensitization; Other: Assessment of depression, anxiety and stress levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of sleep disorders
: Sleep disturbances were assessed with the Pittsburgh Sleep Quality Index (PSQI) . The PSQI is a 19-question questionnaire used to measure sleep habits over the past month and has 7 components. The total score ranges from 0 to 21, with higher scores indicating poor sleep quality. Scores of 5 and above are considered as sleep disturbance.
Measured: baseline
Assessment of depression, anxiety and stress levels
Depression, anxiety and stress levels were assessed using the Depression, Anxiety, Stress Scale (DASS-21). The DASS-21 consists of depression, anxiety and stress subscales, each with 7 questions. A maximum of 42 points can be obtained for each component (the first score is multiplied by two). Higher scores indicate the severity of the respective disorder. Cut-off values are different for each disorder: for depression, 0-9 (normal) to 28 and above (very severe), for anxiety 0-7 (normal) to 20 and above (very severe), and for stress 0-14 (normal) to 34 and above (very severe).
Measured: baseline
Assessment of Central Sensitization
Central sensitization was assessed with the Central Sensitization Inventory (SSI.) The SSE consists of 25 questions. The total score ranges from 0 to 100 and a score of 40 and above indicates the presence of central sensitization.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Sep 2024
- Primary completion19 Nov 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Headache DisorderStudies 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagihan Acet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nagihan Acet, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603493
- Sponsor's protocol ID
- Atılım Physiotherapy
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sariçam, H., The psychometric properties of Turkish version of Depression Anxiety Stress Scale-21 (DASS-21) in health control and clinical samples. Journal of Cognitive Behavioral Psychotherapies and Research, 2018. 7(1): p. 19.
Lovibond, S.H., Manual for the depression anxiety stress scales. Sydney psychology foundation, 1995.
Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
PubMed 21951710Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
PubMed 35382371Ağargün, M.Y., H. Kara, and Ö. Anlar, The validity and reliability of the Pittsburgh Sleep Quality Index. Turk Psikiyatri Derg, 1996. 7(2): p. 107-15.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Pambudi, P. and O. Sidabutar, Correlation between the Degree of Psychological Stress with Pain Intensity in Tension-Type Headache Patients. Jurnal Kedokteran Brawijaya, 2024: p. 6-10.
Suzuki K, Suzuki S, Shiina T, Kobayashi S, Hirata K. Central Sensitization in Migraine: A Narrative Review. J Pain Res. 2022 Sep 7;15:2673-2682. doi: 10.2147/JPR.S329280. eCollection 2022.
PubMed 36101891Sebastianelli G, Casillo F, Abagnale C, Renzo AD, Cioffi E, Parisi V, Lorenzo CD, Fazio F, Petricola F, Mattia C, Serrao M, Schoenen J, Coppola G. Central sensitization mechanisms in chronic migraine with medication overuse headache: a study of thalamocortical activation and lateral cortical inhibition. Cephalalgia. 2023 Oct;43(10):3331024231202240. doi: 10.1177/03331024231202240.
PubMed 37795647van Griensven H, Schmid A, Trendafilova T, Low M. Central Sensitization in Musculoskeletal Pain: Lost in Translation? J Orthop Sports Phys Ther. 2020 Nov;50(11):592-596. doi: 10.2519/jospt.2020.0610.
PubMed 33131390Karna B, Sankari A, Tatikonda G. Sleep Disorder. 2023 Jun 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560720/
PubMed 32809555Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2.
PubMed 35410119R P, S C N, S H, K R. Migraine Disability, Quality of Life, and Its Predictors. Ann Neurosci. 2020 Jan;27(1):18-23. doi: 10.1177/0972753120929563. Epub 2020 Jul 3.
PubMed 32982095Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: A review. Cephalalgia. 2016 Jan;36(1):67-91. doi: 10.1177/0333102415580099. Epub 2015 Apr 17.
PubMed 25888584Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
PubMed 20473702
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Silent Saboteur: The Impact of Headaches on Sleep Disorders, Central Sensitization, Depression, Anxiety and Stress
- ClinicalTrials.gov ID
- NCT06603493
- Acronym / sponsor ID
- Atılım Physiotherapy
- Conditions
- Headache Disorder
- Keywords
- Headache, sleep, Central Nervous System Sensitization, Depression, Anxiety, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nagihan AcetUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Headache is one of the most common health problems in the society and negatively affects the quality of life of individuals. Increasing complaints of headache in recent years can be associated with many physiological and psychological factors. Sleep disturbances are one of these factors. Inadequate or non-restful sleep can interfere with the normal course of physical, mental, social and emotional functions. Impaired sleep quality interferes with the body\'s process of repairing and regenerating itself, which can lead to more serious health problems in the long term. Secondly, headaches can also lead to neurophysiological changes such as central sensitization. Central sensitization causes the nervous system to become hypersensitive, lowering the pain threshold and increasing pain perception. Finally, headache can have psychological effects by increasing levels of depression, anxiety and stress.
This study aimed to determine the effects of headache on sleep disturbances, central sensitization, depression, anxiety and stress.
Detailed description
Headache is one of the most common health problems in the society and types of headache have a significant negative impact on the quality of life of individuals. Headaches can occur in a wide range from temporary discomfort to chronic problems and can negatively affect individuals\' work performance, social life and general health . In recent years, complaints of headache have been increasing in the society. This may be associated with factors such as stress factors of modern life, sleep irregularities and increased use of technology.
One of the factors most affected by headache is sleep disturbance. Especially the presence of migraine can lead to sleep disorders. Sleep disorders consist of various conditions that disrupt normal sleep patterns and are one of the most common problems encountered in clinical practice. Inadequate or non-restful sleep may interfere with the normal course of physical, mental, social and emotional functions. Impaired sleep quality inhibits the body\'s process of self-repair and regeneration, which can lead to more serious health problems in the long term.
Establishing the relationship between sleep and headache can make a significant contribution to the management of headache.
Headaches can also be an important trigger of central sensitization. Central sensitization is an adaptive, activity-dependent and dynamic neurophysiological phenomenon]. This process involves neurobiological changes in neurons in the dorsal horn of the spinal cord.]. These changes include increased excitability, enhanced synaptic transmission and decreased inhibition. In summary, central sensitization is a condition in which the nervous system becomes hypersensitive and pain is perceived as more severe than normal. Especially in individuals with chronic headache, central sensitization may develop as a result of continuous stimulation of the nervous system and this may lead to a decrease in pain threshold and an increase in pain perception. Especially the fact that chronic headache triggers central sensitization is a factor that makes the treatment process very difficult and this situation seriously affects the quality of life of patients.
The psychological effects of headache cannot be ignored. Headache can increase depression, anxiety and stress levels. When pain becomes a constant source of anxiety, it makes it difficult to perform daily activities and negatively affects the general mood of the person. Depression and anxiety can increase the severity of headaches, and headaches can trigger these psychological conditions. Stress can be both a cause and a consequence of headache; especially tension-type headaches are closely related to stress. Therefore, it is important to consider the psychological status in the treatment of headache.
The presence of headache may affect many factors such as sleep disturbance, central sensitization, depression, anxiety and stress, and revealing these effects will contribute to the development of treatment approaches in headache treatment.
In the light of the above information, the aim of the present study was to determine the effect of the presence of headache on sleep disorders, central sensitization, depression, anxiety and stress.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headache Group | – | Other: Assessment of sleep disorders, Other: Assessment of Central Sensitization, Other: Assessment of depression, anxiety and stress levelsindividuals diagnosed with migraine and tension-type headache according to the International Classification of Headache Disorders (International Classification of Headache Disorders, 3rd edition) will be placed in the headache group |
| Control Group | – | Other: Assessment of sleep disorders, Other: Assessment of Central Sensitization, Other: Assessment of depression, anxiety and stress levelsIndividuals aged 18-65 without headaches will be placed in control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18-65 with and without headaches.
Key inclusion criteria (1 listed)
- being 18-65 years who agreed to participate
Key exclusion criteria (4 listed)
- Neurological disorders
- Musculoskeletal diseases
- Chronic pain conditions
- Psychiatric diseases
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 |
|---|---|---|
| Assessment of sleep disorders: Sleep disturbances will be assessed with the Pittsburgh Sleep Quality Index | Other | Control Group, Headache Group |
| Assessment of Central SensitizationCentral sensitization will be assessed with the Central Sensitization Inventory | Other | Control Group, Headache Group |
| Assessment of depression, anxiety and stress levelsDepression, anxiety and stress levels will be assessed using the Depression, Anxiety, Stress Scale (DASS-21) | Other | Control Group, Headache Group |
Primary outcome
Assessment of sleep disorders
Time frame: baseline
: Sleep disturbances were assessed with the Pittsburgh Sleep Quality Index (PSQI) . The PSQI is a 19-question questionnaire used to measure sleep habits over the past month and has 7 components. The total score ranges from 0 to 21, with higher scores indicating poor sleep quality. Scores of 5 and above are considered as sleep disturbance.
Assessment of depression, anxiety and stress levels
Time frame: baseline
Depression, anxiety and stress levels were assessed using the Depression, Anxiety, Stress Scale (DASS-21). The DASS-21 consists of depression, anxiety and stress subscales, each with 7 questions. A maximum of 42 points can be obtained for each component (the first score is multiplied by two). Higher scores indicate the severity of the respective disorder. Cut-off values are different for each disorder: for depression, 0-9 (normal) to 28 and above (very severe), for anxiety 0-7 (normal) to 20 and above (very severe), and for stress 0-14 (normal) to 34 and above (very severe).
Assessment of Central Sensitization
Time frame: baseline
Central sensitization was assessed with the Central Sensitization Inventory (SSI.) The SSE consists of 25 questions. The total score ranges from 0 to 100 and a score of 40 and above indicates the presence of central sensitization.
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 25 Nov 2025.
- Results publicationSariçam, H., The psychometric properties of Turkish version of Depression Anxiety Stress Scale-21 (DASS-21) in health control and clinical samples. Journal of Cognitive Behavioral Psychotherapies and Research, 2018. 7(1): p. 19.
- Results publicationLovibond, S.H., Manual for the depression anxiety stress scales. Sydney psychology foundation, 1995.
- Results publication: PubMed 21951710Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
- Results publication: PubMed 35382371Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
- Results publicationAğargün, M.Y., H. Kara, and Ö. Anlar, The validity and reliability of the Pittsburgh Sleep Quality Index. Turk Psikiyatri Derg, 1996. 7(2): p. 107-15.
- Results publication: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Results publicationPambudi, P. and O. Sidabutar, Correlation between the Degree of Psychological Stress with Pain Intensity in Tension-Type Headache Patients. Jurnal Kedokteran Brawijaya, 2024: p. 6-10.
- Results publication: PubMed 36101891Suzuki K, Suzuki S, Shiina T, Kobayashi S, Hirata K. Central Sensitization in Migraine: A Narrative Review. J Pain Res. 2022 Sep 7;15:2673-2682. doi: 10.2147/JPR.S329280. eCollection 2022.
- Results publication: PubMed 37795647Sebastianelli G, Casillo F, Abagnale C, Renzo AD, Cioffi E, Parisi V, Lorenzo CD, Fazio F, Petricola F, Mattia C, Serrao M, Schoenen J, Coppola G. Central sensitization mechanisms in chronic migraine with medication overuse headache: a study of thalamocortical activation and lateral cortical inhibition. Cephalalgia. 2023 Oct;43(10):3331024231202240. doi: 10.1177/03331024231202240.
- Results publication: PubMed 33131390van Griensven H, Schmid A, Trendafilova T, Low M. Central Sensitization in Musculoskeletal Pain: Lost in Translation? J Orthop Sports Phys Ther. 2020 Nov;50(11):592-596. doi: 10.2519/jospt.2020.0610.
- Results publication: PubMed 32809555Karna B, Sankari A, Tatikonda G. Sleep Disorder. 2023 Jun 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560720/
- Results publication: PubMed 35410119Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Headache Disorder, run by Nagihan Acet 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 1 inclusion and 4 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 25 Nov 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?
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?
Assessment of sleep disorders (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT06603493, which also lists 15 linked publications.
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 Nov 2025.