Effect of Sleep Extension on Ceramides in People With Overweight and Obesity (NCT06180837) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Sleep Extension on Ceramides in People With Overweight and Obesity
United States70 participantsStarted 2024-02-12
Plain-language summary
The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18-45 years old; equal numbers of men and women
. Body mass index (BMI): 27.5-34.9 kg/m2
. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months
Exclusion criteria
. Clinically diagnosed sleep disorder or major psychiatric illness
. Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
. Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at whether sleeping more can lower ceramide levels and improve insulin sensitivity in people with overweight or obesity — given my own sleep habits and metabolic health, is this something worth exploring with my care team?
2Since this is a lifestyle-focused study rather than a drug trial, what kinds of changes to my sleep schedule would likely be required, and do you think those demands would be realistic for my daily life?
3The trial is measuring ceramides, which I understand are lipids linked to insulin resistance and type 2 diabetes risk — can you explain what my current ceramide or insulin sensitivity levels look like, and whether this study's focus is relevant to where I am health-wise?
4Before considering a study like this, should I first try standard approaches to improving my sleep and metabolic health, and how would those compare to what this trial might offer?
5Because this trial is listed as 'Phase NA' — meaning it's not testing a drug — what are the main things I should still watch out for in terms of risks or unknowns, and is there anything about my health history that might make participation less appropriate for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.