NCT06070194 Cardiovascular Risk and Circadian Misalignment in Short Sleepers - Role of Extended Eating Period
| NCT ID | NCT06070194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pennington Biomedical Research Center |
| Condition | Sleep Deprivation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-12-05 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. The study will evaluate if restricted eating duration (8 hours/day) could improve cardiovascular and metabolic health in habitual short sleepers.
Eligibility Criteria
Inclusion 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 \>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 Criteria: * 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.
Contact & Investigator
Prachi Singh, PhD
PRINCIPAL INVESTIGATOR
Pennington Biomedical Research Institute
Frequently Asked Questions
Who can join the NCT06070194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Sleep Deprivation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06070194 currently recruiting?
Yes, NCT06070194 is actively recruiting participants. Contact the research team at prachi.singh@pbrc.edu for enrollment information.
Where is the NCT06070194 trial being conducted?
This trial is being conducted at Baton Rouge, United States.
Who is sponsoring the NCT06070194 clinical trial?
NCT06070194 is sponsored by Pennington Biomedical Research Center. The principal investigator is Prachi Singh, PhD at Pennington Biomedical Research Institute. The trial plans to enroll 100 participants.