Status:
ACTIVE_NOT_RECRUITING
Sleep Quality and the Menstrual Cycle
Lead Sponsor:
University of Akureyri
Collaborating Sponsors:
Akureyri Hospital
Conditions:
Sleep Quality
Eligibility:
FEMALE
18-36 years
Brief Summary
This study aims to examine how ovarian hormone fluctuations across the menstrual cycle affect sleep patterns. Using objective sleep tracking, hormone phase assessment, and validated questionnaires, it...
Detailed Description
Study design: A prospective community-based study focusing on women of reproductive age (18-36 years) designed to evaluate whether the phase of the menstrual cycle affects sleep quality and/or sleep ...
Eligibility Criteria
Inclusion
- Women, 18-36 years
- Body Mass Index (BMI) \<=35
- Regular menstrual cycle, defined as: length of menstrual cycle 22-35 days and length of menses \<10 days.
- Women with natural menstrual cycle (i.e., do not use any type of hormonal contraceptives) and women using contraceptives (comparison group).
Exclusion
- Previously diagnosed with:
- Sleep apnea, clinical insomnia, restless leg syndrome, narcolepsy.
- Shift work and trans-meridian travel during the study period.
- Chronic atrial fibrillation or ventricular trigemini, severe uncontrolled asthma, or other pulmonary diseases.
- Premenstrual Dysphoric Disorder (PMDD) or severe Premenstrual Syndrome (PMS).
- Other severe medical conditions that may affect cerebral metabolism, cancer, diabetes, rheumatoid arthritis, or other chronic health conditions.
- Severe psychiatric conditions, Major Depressive disorder, Generalized Anxiety Disorder, Bipolar Disorder, Personality Disorder, OCD, Schizophrenia.
- Severe neurological conditions, epilepsy, traumatic brain injury, and previous neurosurgery.
- Habitual smokers and other habitual substance abuse or dependence on substances.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06906133
Start Date
March 1 2025
End Date
August 31 2026
Last Update
April 6 2025
Active Locations (2)
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1
Akureyri Hospital
Akureyri, Iceland, IS600
2
University of Akureyri
Akureyri, Iceland, IS600