Brain Fog and Life Quality in Menopause

August 8, 2025 updated by: Merve Coskun

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Ataşehir, İstanbul, Turkey
        • Merve Coşkun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (one-time assessment at enrollment)
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.
At baseline (one-time assessment at enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merve Coskun

Investigators

  • Principal Investigator: Merve Coşkun, Asst. Prof., Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2025

Primary Completion (Actual)

July 16, 2025

Study Completion (Actual)

July 16, 2025

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 15, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-06-251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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