Not Yet RecruitingNot Applicable

Sleep Evaluation Before and After Metabolic Surgery

Netherlands50 participantsStarted 2026-09-01

Plain-language summary

Obesity is frequently associated with sleep disturbances, including poor sleep quality, insomnia symptoms, daytime sleepiness, and obstructive sleep apnea. Metabolic surgery is an effective treatment for obesity and may improve several sleep-related outcomes, but the long-term change in sleep quality after surgery is not well understood. Most previous studies have relied on questionnaires or single-night measurements, which may not fully reflect sleep patterns in daily life. The SLEEP-BAM study is an observational longitudinal cohort study in adults scheduled for primary metabolic surgery at Catharina Hospital Eindhoven, the Netherlands. Participants will complete two home-based sleep measurement periods: one before surgery and one approximately 1 year after surgery. During each period, participants will wear two wearable devices for 5 consecutive nights: a Garmin Index Sleep Monitor and a viQtor research device. Participants will also complete sleep questionnaires and a daily sleep diary. The main aim is to evaluate the change in objective sleep quality from before surgery to 1 year after surgery, measured using the Garmin Sleep Score. Secondary aims include evaluating changes in sleep duration, sleep efficiency, sleep timing, sleep regularity, oxygen saturation, heart rate variability, subjective sleep quality, daytime sleepiness, anxiety and depression symptoms, and quality of life. The study will also explore whether changes in sleep quality are associated with postoperative weight loss. The study does not change the standard surgical treatment. Participants undergo metabolic surgery as part of routine care, and the research procedures consist only of sleep monitoring, questionnaires, and sleep diaries.

Who can participate

Age range

18 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 years or older. * Body mass index (BMI) of 40 kg/m² or higher, or BMI of 35 kg/m² or higher with obesity-related comorbidities. * Scheduled for primary metabolic surgery, including Roux-en-Y gastric bypass, sleeve gastrectomy, or, if performed within standard care, one-anastomosis gastric bypass. * Willing and able to wear wearable devices for 5 consecutive nights during both study measurement periods. * Willing and able to complete sleep questionnaires and a daily sleep diary. * No shift-based or irregular night-shift work schedule that could interfere with sleep measurements. * Able and willing to provide written informed consent. Exclusion Criteria: * Revisional bariatric procedure. * Diagnosed obstructive sleep apnea currently treated with continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP). * High clinical suspicion of obstructive sleep apnea during the standard preoperative work-up requiring further diagnostic evaluation or treatment. * Chronic preoperative use of medications that may significantly alter sleep quality, including benzodiazepines, zolpidem, or other sedatives or sleep aids. * Unable to complete the study procedures or comply with wearable device use, questionnaires, or sleep diary completion.

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

Change in Garmin Sleep Score

Timeframe: Preoperative baseline and approximately 1 year postoperative

Trial details

NCT IDNCT07693491

SponsorCatharina Ziekenhuis Eindhoven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-09-01

Contact for this trial

Ephrahim E Jerry, MD

+31634250807 ephrahim.jerry@catharinaziekenhuis.nl

View on ClinicalTrials.gov More Obesity & Overweight trials