The Effects of Sex Hormones and Alcohol on Sleep
Key facts
- Who runs it
- Ohio State University
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Suspended
- Phase
- Phase 3
- People taking part
- 130 people, planned
- Started
- 8 Jan 2024
- Expected to end
- 1 Nov 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ethanol
- Saline
- Record updated
- 28 September 2026
- Why it stopped
- PI transferring work elsewhere
Who can take part
- Age
- 21 years to 45 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Positive urine screen for illegal drugs other than cannabis
- 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)
- Substance use disorder other than mild or moderate alcohol use disorder
- 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 in United States
- Ohio State UniversityColumbus, United States
About the trial
What the trial wants to find out
Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women, but research on alcohol-related harms in women - including alcohol's impact on sleep - has been minimal. Numerous studies in men show that alcohol impairs sleep, and preliminary evidence suggests that women may be even more sensitive to alcohol-disrupted sleep due to their sex hormones, which fluctuate across both their menstrual cycles and their reproductive lifespans.
Read full original descriptionShow less
This study will investigate the influence of sex, menstrual cycle phase, and sex hormones on alcohol-disrupted sleep in adults ages 21-45. Healthy women and men will complete two sets of placebo-controlled lab sessions, during the mid-follicular and late luteal phases of female participants' menstrual cycles. During these sessions, participants will receive a dose of alcohol or a placebo (saline) and they will then be monitored (with polysomnography) while they sleep. At-home sleep and alcohol use will also be measured through actigraphy, daily sleep and wake diaries, and alcohol wrist sensors.
Investigators hypothesize that women will show greater disruption of sleep following alcohol use or administration than men, and that alcohol-disrupted sleep will be more pronounced in the late luteal phase compared to the mid-follicular phase. Investigators also expect that estradiol will be negatively associated with alcohol-disrupted sleep, whereas progesterone will be positively associated with alcohol-disrupted sleep.
The 4 groups in the trial
- Alcohol Administration - Late Luteal PhaseTreatment being tested
During the late luteal phase of a female participant's menstrual cycle, participants will complete a lab session where alcohol is administered intravenously. The infusion will include a 30-minute linear ascension from 0mg% breath alcohol content (BrAC) to 100mg%, followed by a 60-minute 'clamping' of BrAC at 100mg%. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the placebo session at intervals that are matched to the female subjects. The placebo and alcohol sessions during late luteal phase will take place 1-2 days apart, and their order will be randomized.
Treatment: Ethanol
- Placebo - Late Luteal PhasePlacebo, for comparison
During the late luteal phase of a female participant's menstrual cycle, participants will complete a lab session where saline is administered intravenously, as placebo, for 90 minutes. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the experimental session at intervals that are matched to the female subjects. The placebo and alcohol sessions during late luteal phase will take place 1-2 days apart, and their order will be randomized.
Treatment: Saline
- Alcohol Administration - Mid-Follicular PhaseTreatment being tested
During the mid-follicular phase of a female participant's menstrual cycle, participants will complete a lab session where alcohol is administered intravenously. The infusion will include a 30-minute linear ascension from 0mg% breath alcohol content (BrAC) to 100mg%, followed by a 60-minute 'clamping' of BrAC at 100mg%. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the placebo session at intervals that are matched to the female subjects. The placebo and alcohol sessions during mid-follicular luteal phase will take place 1-2 days apart, and their order will be randomized.
Treatment: Ethanol
- Placebo - Mid-Follicular PhasePlacebo, for comparison
During the mid-follicular phase of a female participant's menstrual cycle, participants will complete a lab session where saline is administered intravenously, as placebo, for 90 minutes. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the experimental session at intervals that are matched to the female subjects. The placebo and alcohol sessions during mid-follicular phase will take place 1-2 days apart, and their order will be randomized.
Treatment: Saline
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sex and Sex Hormone Factors Influencing Acute Alcohol Effects on Sleep Physiology
- Record updated
- 28 September 2026