Clinical trial NCT06978218: Brain Fog and Life Quality in Menopause
Official title: Cognitive Changes in Menopause: A Comparative Analysis of Brain Fog and Quality of Life
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Menopause
Cognitive Dysfunction
Memory Disorders
Quality of Life
Women's Health
Perimenopausal Disorder
Postmenopausal Symptoms
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 82
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive Function Changes and Severity of Brain Fog Symptoms (BFS)
timeFrame: At baseline (one-time assessment at enrollment)
measure: Menopause-Specific Quality of Life (MENQOL)
timeFrame: At baseline (one-time assessment at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Ataşehir
country: Turkey
facility: Merve Coşkun
state: İstanbul
Study officials:
affiliation: Acibadem University
name: Merve Coşkun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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