Status:
RECRUITING
Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Deprivation
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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 sl...
Detailed Description
Short sleep duration is associated with increased cardiovascular and metabolic risk with consequent increased cardiovascular mortality. Increasing sleep duration mitigates the metabolic impairment, bu...
Eligibility Criteria
Inclusion
- 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 \>400 mg/dL or use of lipid lowering medications), diabetes (defined as fasting glucose \>126 mg/dL and /or HbA1C \>6.5%, or use of glucose lowering medication), and cardiovascular disease. However, individuals with prehypertension, and/or prediabetes will be allowed to participate.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06070194
Start Date
December 5 2023
End Date
June 30 2028
Last Update
December 16 2024
Active Locations (1)
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1
Recruiting core Pennington
Baton Rouge, Louisiana, United States, 70808