Effects of sex hormones and alcohol on sleep patterns
Sex and Sex Hormone Factors Influencing Acute Alcohol Effects on Sleep Physiology
PHASE3 · University of Kentucky · NCT06143059
This study is testing how sex hormones and alcohol affect sleep patterns in adults aged 21-45, especially focusing on women during different phases of their menstrual cycles.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06143059 on ClinicalTrials.gov |
What this trial studies
This study investigates how sex, menstrual cycle phases, and sex hormones influence sleep disruption caused by alcohol in adults aged 21-45. Healthy participants will undergo two sets of placebo-controlled lab sessions where they will receive either alcohol or a saline placebo, followed by sleep monitoring using polysomnography. The research aims to understand the unique effects of alcohol on sleep in women, particularly in relation to their hormonal fluctuations throughout their menstrual cycles. Additionally, at-home sleep and alcohol use will be tracked through actigraphy.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21-45 who consume alcohol regularly and have regular ovulatory menstrual cycles if female.
Not a fit: Patients with serious medical conditions, clinical sleep disorders, or psychiatric conditions affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment of sleep disturbances related to alcohol use, particularly in women.
How similar studies have performed: While studies have shown alcohol disrupts sleep in men, this specific investigation into the effects on women across their reproductive lifespan is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 21-45 years old * At least a high school education * Fluency in English * Report drinking at least twice per week and at least weekly binge episodes (4/5+ drinks for women/men in a 2-hour period) * Regular ovulatory menstrual cycles (21-35 days in length) for women Exclusion Criteria: * Any serious medical problems (e.g., liver disease, cardiac abnormality/arrhythmia, pancreatitis, diabetes, neurological problems, gastrointestinal disorders, hypertension, and congestive heart failure) * Any clinical sleep disorder, including insomnia and obstructive sleep apnea (OSA) * Any psychiatric condition that could affect sleep/wake cycles (including major depression, generalized anxiety disorder, bipolar disorder, and post-traumatic stress disorder) * Any medication use that is likely to affect sleep/wake function or cardiovascular functioning (including antidepressants, anxiolytic or soporific medication, and beta-blockers) * Taking medication for which alcohol consumption is contraindicated * Substance use disorder other than mild or moderate alcohol use disorder * Positive urine screen for illegal drugs other than cannabis * Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors * Pregnancy, nursing or planning to become pregnant in the next 3 months for women * Use of hormonal contraception or planning to begin use of hormonal contraception in the next 3 months for women * Reports smoking \> 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions) * Has flushing response to alcohol * Works the night shift
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Study coordinator: Lauren Whitehurst, PhD
- Email: lauren.whitehurst@uky.edu
- Phone: 859-257-4473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, Sex hormones, Sleep disruption