Brain Fog and Life Quality in Menopause

Not yet recruiting

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

• Registration Number: NCT06978218
• Lead Sponsor: Merve Coskun

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study Start: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-09-15
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive Function Changes and Severity of Brain Fog Symptoms (BFS)	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)	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.

Trial Locations

Locations (1)

Merve Coşkun; 🇹🇷 Ataşehir, İstanbul, Turkey