A Sleep Extension Pilot Study in Adults With Obesity (NCT05747105) | Clinical Trial Compass
WithdrawnNot Applicable
A Sleep Extension Pilot Study in Adults With Obesity
Stopped: Unable to move forward with the study due to personnel changes
United States0Started 2023-02-07
Plain-language summary
The pilot study will test the feasibility of a 16-week sleep extension intervention, in adults with obesity, to increase nighttime sleep duration, as well as reduce daytime sleepiness and sleep-related disturbance. The study will also examine changes in weight, eating behaviors, wellbeing, and blood pressure across the 16-week intervention .
Who can participate
Age range
18 Years – 50 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
. Adults, aged 18-50 years old,
. All genders
. Body Mass Index within the obese weight status (BMI of ≥ 30 kg/m2)
. Short sleep duration, defined as sleeping, on average, \<6.5 hours/night for at least 5 nights/week
. Sleep patterns must be stable for the past 6 months
. Weight must be stable (+/- 10 lb) for the past 6 months
. If taking medication for medical or mental health conditions, the condition must be well-controlled with stable dosage (i.e., at least 3 months)
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Percentage of intervention session attendance
Timeframe: Baseline to Week 16 of the intervention
2
Percentage of participants who complete the study
Timeframe: Baseline to Week 16 of the intervention
. Note: Individuals with and without insomnia will be eligible to participate to increase generalizability of the findings. Also, individuals with known obstructive sleep apnea that is being treated and individuals who fall below the "very high risk" category for obstructive sleep apnea (on the ARES screening questionnaire) will be included.
Exclusion criteria
. Specific chronic sleep disorders (e.g., untreated or at very high risk for obstructive sleep apnea, restless leg syndrome, parasomnias, narcolepsy, central apnea, chronic fatigue syndrome, or fibromyalgia)
. Extreme chronotype (i.e., extreme morning or evening sleep patterns)
. Work schedule that is not compatible with sleep habit changes (e.g., night shifts, rotating shift work, or long driving)
. Chronic use of sleep aid or anticonvulsant medications
. Chronic organ disorders (e.g., untreated or uncontrolled diabetes, other endocrine disorders, COPD, chronic cardiac arrhythmia, uncontrolled hypertension or gastro-esophageal disorders)
. Current enrollment in a weight loss program or any active weight loss attempt (e.g., self-directed diet/exercise, over-the-counter supplements, weight management medication)
. History of bariatric surgery (with the exception of an adjustable gastric band that has been removed)
. Mental health disorders judged severe (e.g., major depression, eating disorders, anxiety disorders, bipolar disorder/mania, schizophrenia, active suicidal ideation)