BridgeMD
New treatment option for Sleep Deprivation
Official title Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
ClinicalTrials.gov ID: NCT06070194
What this study is testing
- What it's testing
- Short sleep duration confers high cardiovascular and metabolic risk, but lifestyle factors and molecular mechanisms that contribute to increased blood pressure and poor glucose control during short sleep are not completely understood. Habitual short sleepers are constantly eating, the proposed studies will evaluate if this behavior contributes to heightened cardiovascular and metabolic risk.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Age: 18-45 years
- BMI: 25-35 kg/m2
- Habitual sleep duration: ≤6.5 h/night
- Habitual eating period: \>14h/day
- Absence of chronic health conditions including hypertension (defined as systolic clinical BP of \>140 or diastolic BP of \>90 mmHg or use of BP...
You likely can't join if
- Irregular sleep habits / night shift / rotating shift work in past 1 month.
- Frequent travel related jet lag.
- Pregnant/ breast-feeding/ history of irregular menstrual cycles.
- Sleep disorders such as insomnia (defined as Insomnia Severity Index score ≥15), and sleep apnea (overnight oximetry defined oxygen desaturation...
- Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score \>10).
- Recent changes in body weight (≥5%) within 3 months.
See the full eligibility criteria
- Age: 18-45 years
- BMI: 25-35 kg/m2
- Habitual sleep duration: ≤6.5 h/night
- Habitual eating period: \>14h/day
- Absence of chronic health conditions including hypertension (defined as systolic clinical BP of \>140 or diastolic BP of \>90 mmHg or use of BP lowering drugs), dyslipidemia (defined as LDL \>190mg/dL or Triglycerides...
- Individuals with seasonal allergies will also be included.
- Women of child-bearing age will be allowed to participate if they agree to use acceptable birth control during the study period.
- Must be able to provide written informed consent.
- Ability to follow the prescribed eating duration and maintain habitual diet, sleep and physical activity.
- Use of certain mediations will be allowed including birth control, second generation antihistamines, antacids, acne-related ointments etc.
- Irregular sleep habits / night shift / rotating shift work in past 1 month.
- Frequent travel related jet lag.
- Pregnant/ breast-feeding/ history of irregular menstrual cycles.
- Sleep disorders such as insomnia (defined as Insomnia Severity Index score ≥15), and sleep apnea (overnight oximetry defined oxygen desaturation index of \>10 events/h of sleep).
- Presence of excessive daytime sleepiness (defined as Epworth Sleepiness Scale score \>10).
- Recent changes in body weight (≥5%) within 3 months.
- Uncontrolled depression and /or anxiety, history of psychosis or bipolar disorder.
- Uncontrolled depression and/or depression is defined as PHQ-9 score of ≥15 or a positive response for suicidal thoughts (Q9 of the PHQ-9 - any response other than not at all).
- Any medication or condition that, in the opinion of the medical investigator, could interfere with the study outcomes or put the subject at risk by participating in the study.
- Blood or plasma donation during the past 2 months.
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.