Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143059
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-11-15
Brief Title:
The Effects of Sex Hormones and Alcohol on Sleep
Sponsor:
Lauren Whitehurst
Organization:
University of Kentucky
Study Overview
Official Title:
Sex and Sex Hormone Factors Influencing Acute Alcohol Effects on Sleep Physiology
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rates of heavy drinking and Alcohol Use Disorder AUD are increasing in women but research on alcohol-related harms in women - including alcohols 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
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
Detailed Description:
Rates of heavy drinking and Alcohol Use Disorder AUD are increasing in women at an alarming pace Such drastic increases in drinking will have a significant negative impact on womens health Unfortunately until recently heavy drinking has been considered a male-oriented problem and consequently research on alcohol-related harms in women has been minimal One specific aspect of womens health that may be negatively affected by alcohol is sleep Numerous studies in men show that although alcohol has an initial sedative effect it leads to frequent awakenings and impaired rapid eye movement sleep in the second half of the night
Preliminary evidence suggests that women experience similar impairment and that they may be even more sensitive to alcohol-disrupted sleep than men Further in the general population women are at greater risk for insomnia and sleep disturbances than men in part because womens sleep is sensitive to fluctuations in ovarian hormones Hormonal influences on sleep are especially pronounced in older women of late reproductive age However the influence of sex and sex hormones on alcohol-disrupted sleep across the reproductive lifespan in women is unknown
Here investigators will determine the influence of sex menstrual cycle phase and sex hormones on alcohol-disrupted sleep in adults across the reproductive age range for women Healthy women and men age 21-45 will complete two pairs of experimental sessions in which they receive a dose of alcohol target breath alcohol content BrAC 100mg intravenous or placebo saline one hour prior to eight hours of polysomnographically-monitored sleep in the lab Women will complete one alcohol-placebo session pair during the mid-follicular phase of the menstrual cycle and one pair during the late luteal phase Men will complete two session pairs at matched intervals Participants will also complete two 5-day at-home monitoring periods of naturalistic sleep and alcohol consumption patterns during the mid-follicular and late luteal phases Sleep and alcohol use will be assessed with actigraphy daily sleep and wake diaries and alcohol wrist sensors
Investigators hypothesize that women will show greater disruption of sleep following alcohol than men and that alcohol-disrupted sleep measured in lab with polysomnography and at-home with actigraphy 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
This study will provide essential information regarding alcohol effects on sleep across the reproductive age span in women and critically how these effects are moderated by sex menstrual cycle and fluctuations in sex hormones Findings will directly inform future interventions aimed at reducing alcohol consumption and the negative impacts of alcohol on sleep in women Given the wide-ranging impact of sleep on other areas of function including cognition stress and well-being such interventions will have a substantial positive impact on womens health
Preliminary evidence suggests that women experience similar impairment and that they may be even more sensitive to alcohol-disrupted sleep than men Further in the general population women are at greater risk for insomnia and sleep disturbances than men in part because womens sleep is sensitive to fluctuations in ovarian hormones Hormonal influences on sleep are especially pronounced in older women of late reproductive age However the influence of sex and sex hormones on alcohol-disrupted sleep across the reproductive lifespan in women is unknown
Here investigators will determine the influence of sex menstrual cycle phase and sex hormones on alcohol-disrupted sleep in adults across the reproductive age range for women Healthy women and men age 21-45 will complete two pairs of experimental sessions in which they receive a dose of alcohol target breath alcohol content BrAC 100mg intravenous or placebo saline one hour prior to eight hours of polysomnographically-monitored sleep in the lab Women will complete one alcohol-placebo session pair during the mid-follicular phase of the menstrual cycle and one pair during the late luteal phase Men will complete two session pairs at matched intervals Participants will also complete two 5-day at-home monitoring periods of naturalistic sleep and alcohol consumption patterns during the mid-follicular and late luteal phases Sleep and alcohol use will be assessed with actigraphy daily sleep and wake diaries and alcohol wrist sensors
Investigators hypothesize that women will show greater disruption of sleep following alcohol than men and that alcohol-disrupted sleep measured in lab with polysomnography and at-home with actigraphy 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
This study will provide essential information regarding alcohol effects on sleep across the reproductive age span in women and critically how these effects are moderated by sex menstrual cycle and fluctuations in sex hormones Findings will directly inform future interventions aimed at reducing alcohol consumption and the negative impacts of alcohol on sleep in women Given the wide-ranging impact of sleep on other areas of function including cognition stress and well-being such interventions will have a substantial positive impact on womens health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA030308 | NIH | None | httpsreporternihgovquickSearchR01AA030308 |