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Controlled Sleep for Menstrual Cycle-Related Sleep Deprivation
N/A
Recruiting
Led By Melissa A St. Hilaire, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
Weight >110 lb
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the pvt will be administered at frequent intervals over 11 days in a sleep laboratory. subjects will be in a time-free environment, and not told the sampling frequency.
Awards & highlights
Study Summary
This trial looks at the effects of sleep loss on premenopausal women at different times in their menstrual cycle.
Who is the study for?
This trial is for healthy premenopausal women aged 18-35 with a BMI of 18.5-29.5 kg/m2 and weight over 110 lb. Participants should have regular menstrual cycles (26-35 days) and sleep patterns (7-9 hours/night), not use hormonal contraception for the past 3 months, or take any medications or supplements.Check my eligibility
What is being tested?
The study examines how different sleep loss patterns affect healthy women at various stages of their menstrual cycle. It involves controlled sleep conditions to understand the impact on participants' responses during these times.See study design
What are the potential side effects?
Since this trial involves controlled sleep rather than medication, there are no direct side effects like those from drugs; however, participants may experience tiredness or changes in mood due to altered sleeping patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
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I weigh more than 110 pounds.
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I am between 18 and 35 years old.
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I am not currently taking any medications or supplements.
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I am between 18 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the kss will be administered at frequent intervals over 11 days in a sleep laboratory. subjects will be in a time-free environment, and not told the sampling frequency.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the kss will be administered at frequent intervals over 11 days in a sleep laboratory. subjects will be in a time-free environment, and not told the sampling frequency.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Core body temperature
KSS score
P4/E2 ratio
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Control sleep - luteal phaseExperimental Treatment1 Intervention
This will be the fourth of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
Group II: Control sleep - follicular phaseExperimental Treatment1 Intervention
This will be the third of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
Group III: Chronic variable sleep deficiency - luteal phaseExperimental Treatment1 Intervention
This will be the second of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
Group IV: Chronic variable sleep deficiency - follicular phaseExperimental Treatment1 Intervention
This will be the first of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Controlled sleep
2020
N/A
~60
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,527 Total Patients Enrolled
11 Trials studying Sleep Deprivation
4,709 Patients Enrolled for Sleep Deprivation
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,470,730 Total Patients Enrolled
6 Trials studying Sleep Deprivation
3,925 Patients Enrolled for Sleep Deprivation
Melissa A St. Hilaire, PhDPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am female.I weigh more than 110 pounds.I am between 18 and 35 years old.You usually sleep 7 to 9 hours every night.I have a condition like diabetes, a metabolic disorder, or a psychiatric illness.Your weight is within a certain range based on your height.You have traveled across multiple time zones in the past 3 months.I have been diagnosed with a primary sleep disorder.I am not currently taking any medications or supplements.You have a very early or very late sleep schedule.You have donated blood in the last 8 weeks.You have a regular period that comes every 26 to 35 days.You have worked in shifts in the past.I am between 18 and 35 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control sleep - follicular phase
- Group 2: Control sleep - luteal phase
- Group 3: Chronic variable sleep deficiency - follicular phase
- Group 4: Chronic variable sleep deficiency - luteal phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently taking part in this research investigation?
"Affirmative. The information hosted on clinicaltrials.gov affirms that this research is currently seeking participants, which were first announced in October 17th 2022 and last updated later 21st November of the same year. This study aims to acquire 100 individuals from one medical centre alone."
Answered by AI
Do I fulfill the criteria to partake in this experiment?
"This research study is looking for 100 participants, aged 18 to 35 years old, who are suffering from sleep debt. Other key criteria include: female gender identity; a regular menstrual cycle between 26-35 days long; no current medication or supplement use; bodyweight greater than 110 pounds; BMI between 18.5 and 29.5 kg/m2 ; abstaining from hormonal contraception over the past 3 months; and typical sleeping patterns of 7-9 hours per night."
Answered by AI
Are new participants being added to this clinical experiment presently?
"Affirmative. According to clinicaltrials.gov, the trial which was initially published on October 17th 2022 is currently recruiting participants with a goal of 100 individuals from 1 site. It has been recently updated on November 21st 2021."
Answered by AI
Does this trial admit adults aged 18 and above?
"This study seeks participants aged 18-35 years to join the trial."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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