MenopauseNCT06978218
Brain Fog and Life Quality in Menopause
An observational study of Menopause and Cognitive Dysfunction, run by Merve Coskun at 1 site in Turkey (Türkiye).
Trial summary
This clinical study aims to investigate cognitive changes in women undergoing the menopausal transition, with a specific focus on the prevalence, characteristics, and impact of brain fog. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Cognitive Dysfunction, Memory Disorders
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 16 Jul 2025
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consists of women aged between 40 and 60 years who are experiencing or have experienced menopause. The participants will be selected from women at different stages of menopause, including peri-menopause, menopause, and post-menopause. The study aims to include a diverse group of women to understand the variations in cognitive changes and quality of life during different stages of menopause.
Who may be able to join
- Aged between 40 and 60 years.
- In any stage of menopause.
- Able to complete the Brain Fog Scale and Menopause-Specific Quality of Life Scale due to cognitive and physical capability.
- Willing to participate in the study voluntarily.
- Able to read and write in Turkish.
Who cannot join
- Diagnosed with neurological or psychiatric disorders (e.g., Alzheimer's, Dementia, Schizophrenia, etc.).
- Currently receiving hormone therapy.
- Experiencing menstrual irregularities due to reasons other than menopause.
- Unable to complete the scales due to visual impairment or significant cognitive limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Changes in Menopause: A Comparative Analysis of Brain Fog and Quality of Life
This clinical study aims to investigate cognitive changes in women undergoing the menopausal transition, with a specific focus on the prevalence, characteristics, and impact of brain fog. The research will assess how declining estrogen levels influence cognitive domains such as memory, attention, and executive function across different menopausal stages (perimenopause, menopause, and postmenopause). Through a comparative and observational design, the study will evaluate the relationship between subjective cognitive complaints and menopause-specific quality of life. Findings are expected to inform the development of non-pharmacological strategies-such as lifestyle modifications and cognitive health interventions-to mitigate cognitive decline and improve overall well-being in midlife women.
Read the detailed description
Menopause is a natural biological process characterized by a decline in ovarian function and a marked reduction in estrogen and progesterone levels, often accompanied by elevated follicle-stimulating hormone (FSH) levels. These hormonal changes are known to influence various physiological and psychological domains, including cognitive functioning. Recent evidence suggests that many women report subjective cognitive difficulties during the menopausal transition, commonly described as "brain fog," which includes symptoms such as forgetfulness, difficulty concentrating, slowed thinking, and word-finding problems.
This study is designed to systematically examine the nature and extent of cognitive changes during the menopausal transition, with a focus on comparing different stages-perimenopause, menopause, and postmenopause. Using validated cognitive screening tools and self-report measures, the study will assess domains including attention, memory, and executive function, and evaluate how these relate to menopause-specific quality of life.
In addition to cognitive assessments, participants will complete surveys addressing mood, sleep quality, physical activity, and perceived stress, as these are potential moderators or mediators of cognitive function during menopause. The study also aims to explore correlations between the severity of brain fog symptoms and demographic or lifestyle-related factors such as age, BMI, education level, and health behaviors.
By adopting a cross-sectional comparative approach, this research seeks to better characterize brain fog as a clinical concern in menopausal women and to identify vulnerable subgroups who may benefit from targeted cognitive and lifestyle interventions. The findings are expected to contribute to the growing body of knowledge on neuroendocrinology and women's brain health, and may support the development of tailored clinical guidelines or integrative care models for managing cognitive complaints during menopause.
- Conditions
- Menopause, Cognitive Dysfunction, Memory Disorders, Quality of Life, Women's Health, Perimenopausal Disorder
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function Changes and Severity of Brain Fog Symptoms (BFS)
The primary outcome measure of this study is to assess changes in cognitive function and the severity of brain fog symptoms in women at different stages of menopause (peri-menopause, menopause, and post-menopause). The Brain Fog Scale allows participants to subjectively assess their brain fog symptoms, including forgetfulness, difficulty focusing, mental slowing, and trouble finding words. Measurement Content:
Mental Fatigue: Feelings of mental tiredness and its impact on daily life.
Impaired Cognitive Sharpness: Issues related to attention, memory, and cognitive clarity.
Mental Cloudiness: Loss of mental clarity and difficulty organizing thoughts.
Scoring System: The BFS uses a 5-point Likert scale (0: Never, 4: Always) to assess symptoms. Higher scores indicate more pronounced brain fog symptoms.
Measured: At baseline (one-time assessment at enrollment)
Menopause-Specific Quality of Life (MENQOL)
The primary outcome measure of this study is to evaluate the impact of menopause on the overall quality of life (QOL) in women at different stages of menopause (peri-menopause, menopause, and post-menopause). The MENQOL assesses various aspects of life that are influenced by menopause, including physical, psychosocial, sexual, and vasomotor symptoms.The MENQOL uses a 7-point Likert scale, with scores ranging from 0 (no problem) to 6 (severe problem). Higher scores indicate greater severity of symptoms and a lower quality of life related to menopause.
Measured: At baseline (one-time assessment at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start8 May 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Coskun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Coskun, Acibadem University
- Investigators
- Merve Coşkun, Asst. Prof., Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978218
- Sponsor's protocol ID
- 2025-06-251
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhu C, Thomas EH, Li Q, Arunogiri S, Thomas N, Gurvich C. Evaluation of the Everyday Memory Questionnaire-Revised in a menopausal population: understanding the brain fog during menopause. Menopause. 2023 Nov 1;30(11):1147-1156. doi: 10.1097/GME.0000000000002256. Epub 2023 Oct 2.
PubMed 37788429Shrividya, S., & Joy, M. (2021). Brain fog among perimenopausal women: A comparative study. Journal of International Women's Studies, 22(6), 11-21.
Mosconi L, Rahman A, Diaz I, Wu X, Scheyer O, Hristov HW, Vallabhajosula S, Isaacson RS, de Leon MJ, Brinton RD. Increased Alzheimer's risk during the menopause transition: A 3-year longitudinal brain imaging study. PLoS One. 2018 Dec 12;13(12):e0207885. doi: 10.1371/journal.pone.0207885. eCollection 2018.
PubMed 30540774Bean, L. A., Ianov, L., & Foster, T. C. (2021). Estrogen receptors, the hippocampus, and memory: Neural systems approach to understanding estrogen function. Hormones and Behavior, 127, 104893.
Bas M, Kahriman M, Gencalp C, Koseoglu SK, Hajhamidiasl L. Adaptation and Validation of the Turkish Version of the Brain Fog Scale. Int J Environ Res Public Health. 2024 Jun 14;21(6):774. doi: 10.3390/ijerph21060774.
PubMed 38929020Debowska, A., Boduszek, D., Ochman, M., Hrapkowicz, T., Gaweda, M., Pondel, A., & Horeczy, B. (2024). Brain Fog Scale (BFS): scale development and validation. Personality and Individual Differences, 216, 112427.
Polit, D., & Beck, C. (2017). Nursing research : generating and assessing evidence for nursing practice (10th ed.). Lippincott Williams & Wilkins. ISBN 978-1-4963-0023-2, ss-380, 563-564
Lee KS, Jung MS, Kim M, Cha K, Chung E. Impact of Cognitive Aging on Health-Related Quality of Life in Menopausal Women. Osong Public Health Res Perspect. 2020 Aug;11(4):185-193. doi: 10.24171/j.phrp.2020.11.4.07.
PubMed 32864309Gümüşay, M., & Erbil, N. (2019). Kadınların menopoza özgü yaşam kalitesine menopoz tutumunun etkisi. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 2(2), 96-109.
Kuck MJ, Hogervorst E. Stress, depression, and anxiety: psychological complaints across menopausal stages. Front Psychiatry. 2024 Feb 22;15:1323743. doi: 10.3389/fpsyt.2024.1323743. eCollection 2024.
PubMed 38455517Maki PM, Jaff NG. Brain fog in menopause: a health-care professional's guide for decision-making and counseling on cognition. Climacteric. 2022 Dec;25(6):570-578. doi: 10.1080/13697137.2022.2122792. Epub 2022 Sep 30.
PubMed 36178170Maki PM, Jaff NG. Menopause and brain fog: how to counsel and treat midlife women. Menopause. 2024 Jul 1;31(7):647-649. doi: 10.1097/GME.0000000000002382. Epub 2024 Jun 17.
PubMed 38888619
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes in Menopause: A Comparative Analysis of Brain Fog and Quality of Life
- ClinicalTrials.gov ID
- NCT06978218
- Acronym / sponsor ID
- 2025-06-251
- Conditions
- Menopause, Cognitive Dysfunction, Memory Disorders, Quality of Life, Women's Health, Perimenopausal Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Merve CoskunUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 18 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.
This clinical study aims to investigate cognitive changes in women undergoing the menopausal transition, with a specific focus on the prevalence, characteristics, and impact of brain fog. The research will assess how declining estrogen levels influence cognitive domains such as memory, attention, and executive function across different menopausal stages (perimenopause, menopause, and postmenopause). Through a comparative and observational design, the study will evaluate the relationship between subjective cognitive complaints and menopause-specific quality of life. Findings are expected to inform the development of non-pharmacological strategies-such as lifestyle modifications and cognitive health interventions-to mitigate cognitive decline and improve overall well-being in midlife women.
Detailed description
Menopause is a natural biological process characterized by a decline in ovarian function and a marked reduction in estrogen and progesterone levels, often accompanied by elevated follicle-stimulating hormone (FSH) levels. These hormonal changes are known to influence various physiological and psychological domains, including cognitive functioning. Recent evidence suggests that many women report subjective cognitive difficulties during the menopausal transition, commonly described as "brain fog," which includes symptoms such as forgetfulness, difficulty concentrating, slowed thinking, and word-finding problems.
This study is designed to systematically examine the nature and extent of cognitive changes during the menopausal transition, with a focus on comparing different stages-perimenopause, menopause, and postmenopause. Using validated cognitive screening tools and self-report measures, the study will assess domains including attention, memory, and executive function, and evaluate how these relate to menopause-specific quality of life.
In addition to cognitive assessments, participants will complete surveys addressing mood, sleep quality, physical activity, and perceived stress, as these are potential moderators or mediators of cognitive function during menopause. The study also aims to explore correlations between the severity of brain fog symptoms and demographic or lifestyle-related factors such as age, BMI, education level, and health behaviors.
By adopting a cross-sectional comparative approach, this research seeks to better characterize brain fog as a clinical concern in menopausal women and to identify vulnerable subgroups who may benefit from targeted cognitive and lifestyle interventions. The findings are expected to contribute to the growing body of knowledge on neuroendocrinology and women's brain health, and may support the development of tailored clinical guidelines or integrative care models for managing cognitive complaints during menopause.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of women aged between 40 and 60 years who are experiencing or have experienced menopause. The participants will be selected from women at different stages of menopause, including peri-menopause, menopause, and post-menopause. The study aims to include a diverse group of women to understand the variations in cognitive changes and quality of life during different stages of menopause.
Key inclusion criteria (5 listed)
- Aged between 40 and 60 years.
- In any stage of menopause.
- Able to complete the Brain Fog Scale and Menopause-Specific Quality of Life Scale due to cognitive and physical capability.
- Willing to participate in the study voluntarily.
- Able to read and write in Turkish.
Key exclusion criteria (4 listed)
- Diagnosed with neurological or psychiatric disorders (e.g., Alzheimer's, Dementia, Schizophrenia, etc.).
- Currently receiving hormone therapy.
- Experiencing menstrual irregularities due to reasons other than menopause.
- Unable to complete the scales due to visual impairment or significant cognitive limitations.
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
Cognitive Function Changes and Severity of Brain Fog Symptoms (BFS)
Time frame: At baseline (one-time assessment at enrollment)
The primary outcome measure of this study is to assess changes in cognitive function and the severity of brain fog symptoms in women at different stages of menopause (peri-menopause, menopause, and post-menopause). The Brain Fog Scale allows participants to subjectively assess their brain fog symptoms, including forgetfulness, difficulty focusing, mental slowing, and trouble finding words. Measurement Content: Mental Fatigue: Feelings of mental tiredness and its impact on daily life. Impaired Cognitive Sharpness: Issues related to attention, memory, and cognitive clarity. Mental Cloudiness: Loss of mental clarity and difficulty organizing thoughts. Scoring System: The BFS uses a 5-point Likert scale (0: Never, 4: Always) to assess symptoms. Higher scores indicate more pronounced brain fog symptoms.
Menopause-Specific Quality of Life (MENQOL)
Time frame: At baseline (one-time assessment at enrollment)
The primary outcome measure of this study is to evaluate the impact of menopause on the overall quality of life (QOL) in women at different stages of menopause (peri-menopause, menopause, and post-menopause). The MENQOL assesses various aspects of life that are influenced by menopause, including physical, psychosocial, sexual, and vasomotor symptoms.The MENQOL uses a 7-point Likert scale, with scores ranging from 0 (no problem) to 6 (severe problem). Higher scores indicate greater severity of symptoms and a lower quality of life related to menopause.
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 2025.
- Background: PubMed 37788429Zhu C, Thomas EH, Li Q, Arunogiri S, Thomas N, Gurvich C. Evaluation of the Everyday Memory Questionnaire-Revised in a menopausal population: understanding the brain fog during menopause. Menopause. 2023 Nov 1;30(11):1147-1156. doi: 10.1097/GME.0000000000002256. Epub 2023 Oct 2.
- BackgroundShrividya, S., & Joy, M. (2021). Brain fog among perimenopausal women: A comparative study. Journal of International Women's Studies, 22(6), 11-21.
- Background: PubMed 30540774Mosconi L, Rahman A, Diaz I, Wu X, Scheyer O, Hristov HW, Vallabhajosula S, Isaacson RS, de Leon MJ, Brinton RD. Increased Alzheimer's risk during the menopause transition: A 3-year longitudinal brain imaging study. PLoS One. 2018 Dec 12;13(12):e0207885. doi: 10.1371/journal.pone.0207885. eCollection 2018.
- BackgroundBean, L. A., Ianov, L., & Foster, T. C. (2021). Estrogen receptors, the hippocampus, and memory: Neural systems approach to understanding estrogen function. Hormones and Behavior, 127, 104893.
- Background: PubMed 38929020Bas M, Kahriman M, Gencalp C, Koseoglu SK, Hajhamidiasl L. Adaptation and Validation of the Turkish Version of the Brain Fog Scale. Int J Environ Res Public Health. 2024 Jun 14;21(6):774. doi: 10.3390/ijerph21060774.
- BackgroundDebowska, A., Boduszek, D., Ochman, M., Hrapkowicz, T., Gaweda, M., Pondel, A., & Horeczy, B. (2024). Brain Fog Scale (BFS): scale development and validation. Personality and Individual Differences, 216, 112427.
- BackgroundPolit, D., & Beck, C. (2017). Nursing research : generating and assessing evidence for nursing practice (10th ed.). Lippincott Williams & Wilkins. ISBN 978-1-4963-0023-2, ss-380, 563-564
- Background: PubMed 32864309Lee KS, Jung MS, Kim M, Cha K, Chung E. Impact of Cognitive Aging on Health-Related Quality of Life in Menopausal Women. Osong Public Health Res Perspect. 2020 Aug;11(4):185-193. doi: 10.24171/j.phrp.2020.11.4.07.
- BackgroundGümüşay, M., & Erbil, N. (2019). Kadınların menopoza özgü yaşam kalitesine menopoz tutumunun etkisi. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 2(2), 96-109.
- Background: PubMed 38455517Kuck MJ, Hogervorst E. Stress, depression, and anxiety: psychological complaints across menopausal stages. Front Psychiatry. 2024 Feb 22;15:1323743. doi: 10.3389/fpsyt.2024.1323743. eCollection 2024.
- Results publication: PubMed 36178170Maki PM, Jaff NG. Brain fog in menopause: a health-care professional's guide for decision-making and counseling on cognition. Climacteric. 2022 Dec;25(6):570-578. doi: 10.1080/13697137.2022.2122792. Epub 2022 Sep 30.
- Results publication: PubMed 38888619Maki PM, Jaff NG. Menopause and brain fog: how to counsel and treat midlife women. Menopause. 2024 Jul 1;31(7):647-649. doi: 10.1097/GME.0000000000002382. Epub 2024 Jun 17.
- 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.
Merve Coşkun, Asst. Prof. principal investigator
Acibadem 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 Menopause and Cognitive Dysfunction, run by Merve Coskun 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 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 11 Aug 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?
Cognitive Function Changes and Severity of Brain Fog Symptoms (BFS) (time frame: At baseline (one-time assessment at enrollment)). 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?
On the ClinicalTrials.gov record for NCT06978218, which also lists 12 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 11 Aug 2025.