SUSPENDED

The Effects of Sex Hormones and Alcohol on Sleep

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. 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.

Official Title

Sex and Sex Hormone Factors Influencing Acute Alcohol Effects on Sleep Physiology

Quick Facts

Study Start:2024-01-08
Study Completion:2028-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06143059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 21-45 years old
  2. * At least a high school education
  3. * Fluency in English
  4. * Report drinking at least twice per week and at least weekly binge episodes (4/5+ drinks for women/men in a 2-hour period)
  5. * Regular ovulatory menstrual cycles (21-35 days in length) for women
  1. * Any serious medical problems (e.g., liver disease, cardiac abnormality/arrhythmia, pancreatitis, diabetes, neurological problems, gastrointestinal disorders, hypertension, and congestive heart failure)
  2. * Any clinical sleep disorder, including insomnia and obstructive sleep apnea (OSA)
  3. * Any psychiatric condition that could affect sleep/wake cycles (including major depression, generalized anxiety disorder, bipolar disorder, and post-traumatic stress disorder)
  4. * Any medication use that is likely to affect sleep/wake function or cardiovascular functioning (including antidepressants, anxiolytic or soporific medication, and beta-blockers)
  5. * Taking medication for which alcohol consumption is contraindicated
  6. * Substance use disorder other than mild or moderate alcohol use disorder
  7. * Positive urine screen for illegal drugs other than cannabis
  8. * Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
  9. * Pregnancy, nursing or planning to become pregnant in the next 3 months for women
  10. * Use of hormonal contraception or planning to begin use of hormonal contraception in the next 3 months for women
  11. * Reports smoking \> 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)
  12. * Has flushing response to alcohol
  13. * Works the night shift

Contacts and Locations

Principal Investigator

Lauren Whitehurst, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40508
United States

Collaborators and Investigators

Sponsor: Lauren Whitehurst

  • Lauren Whitehurst, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08
Study Completion Date2028-11-01

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

  • Sex hormones
  • Sleep disruption

Additional Relevant MeSH Terms

  • Alcohol Use Disorder