Obesity, severe obesity, morbid obesity, metabolic obesity, Sleep disturbance, poor sleep quality, sleep problems Severe overweight, Sleeping problems
Conditions
Interventions
Participants will wear two wearable sleep monitoring devices and complete sleep questionnaires and sleep diaries. No therapeutic intervention is performed.
Sponsors
Catharina Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults scheduled for primary metabolic bariatric surgery at Catharina Hospital Eindhoven. Participants must be aged =18 years with a BMI =40 kg/m², or BMI =35 kg/m² with obesity-related comorbidities. Participants must be willing and able to wear wearable monitoring devices for five consecutive nights during both measurement periods (preoperative and 12 months postoperative). Participants must be willing and able to complete sleep questionnaires and a daily sleep diary. Participants must provide written informed consent. Participants must have a regular sleep–wake schedule and not perform shift-based or night-shift work.
Exclusion criteria
Exclusion criteria: Participants with diagnosed obstructive sleep apnea currently treated with CPAP or BiPAP. Participants with a high clinical suspicion of obstructive sleep apnea during preoperative screening. Participants using sedative, hypnotic, or sleep-inducing medication (e.g., benzodiazepines, zolpidem, or similar agents) on a chronic preoperative basis. Participants performing shift work or irregular night work. Participants unable to wear wearable devices or complete questionnaires. Participants unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in sleep quality measured by the Garmin Sleep Score between baseline and 12 months postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include changes in objective sleep parameters (total sleep time, sleep efficiency, sleep latency, REM sleep, nocturnal awakenings, SpO2, heart rate variability, and sleep timing parameters), changes in subjective sleep measures (PSQI, ESS, HADS, sleep diary), comparison between objective and subjective sleep measures, and associations between sleep quality and postoperative weight loss and quality of life. | — |
Countries
Netherlands
Contacts
Public ContactA. Burmanje
Catharina Ziekenhuis
Outcome results
None listed