Brain Fog and Life Quality in Menopause

NCT06978218 | Completed

• 1 other identifier: 2025-06-251
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Menopause; Cognitive Dysfunction; Memory Disorders; Quality of Life; Women's Health; Perimenopausal Disorder; Postmenopausal Symptoms

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At baseline (one-time assessment at enrollment)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: The study is designed to evaluate the cognitive changes, brain fog, and quality of life specifically in women undergoing menopause. Therefore, only female participants who are currently experiencing or have experienced menopause are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merve Coskun: lead

Study Sites (1)

Merve Coşkun

Ataşehir, Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 37788429 BACKGROUND

• Shrividya, S., & Joy, M. (2021). Brain fog among perimenopausal women: A comparative study. Journal of International Women's Studies, 22(6), 11-21.

  BACKGROUND

• 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.

  PMID: 30540774 BACKGROUND

• Bean, 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

• 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.

  PMID: 38929020 BACKGROUND

• Debowska, 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32864309 BACKGROUND

• Gümüşay, M., & Erbil, N. (2019). Kadınların menopoza özgü yaşam kalitesine menopoz tutumunun etkisi. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 2(2), 96-109.

  BACKGROUND

• 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.

  PMID: 38455517 BACKGROUND

• Maki 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.

  PMID: 36178170 RESULT

• Maki 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.

  PMID: 38888619 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve Coşkun, Asst. Prof.

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: May 8, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

TU (1)