Wearable sleep trackers reveal how Weight-Loss surgery changes rest

NCT ID NCT07693491

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tracks sleep quality in adults with obesity before and one year after metabolic surgery (gastric bypass or sleeve gastrectomy). Participants wear two sleep-monitoring devices for five nights at home and fill out sleep questionnaires and diaries. The goal is to see whether surgery leads to lasting improvements in sleep, beyond what short lab tests can show.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metabolic surgery (gastric bypass or sleeve gastrectomy)
What this could lead to
If sleep quality improves significantly after surgery, this could point toward better ways to manage sleep problems in people with obesity.
What could go wrong
This is an observational study with only 50 participants, so results may not apply to everyone. The sleep monitors are not medical devices and may not capture all sleep issues accurately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with obesity scheduled for primary metabolic surgery at Catharina Hospital Eindhoven, the Netherlands. Eligible participants will undergo Roux-en-Y gastric bypass, sleeve gastrectomy, or, if performed within standard care, one-anastomosis gastric bypass. Participants will complete home-based sleep monitoring before surgery and approximately 1 year after surgery.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Catharina ziekenhuis Eindhoven

    Eindhoven, North Brabant, 5623EJ, Netherlands

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