Sleep Evaluation Before and After Metabolic Surgery

Sponsor
Catharina Ziekenhuis Eindhoven
Study ID
NCT07693491
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Metabolic Surgery
  • Obesity & Overweight
  • Obesity & Overweight Sleep
  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Primary Metabolic Surgery — PROCEDURE
    Primary metabolic surgery performed as part of routine clinical care, including Roux-en-Y gastric bypass, sleeve gastrectomy, and, if performed within standard care, one-anastomosis gastric bypass. Revisional bariatric procedures are excluded.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Patients Undergoing Primary Metabolic Surgery
    Adults with obesity scheduled for primary metabolic surgery at Catharina Hospital Eindhoven. Participants will undergo metabolic surgery as part of routine clinical care and will complete home-based sleep monitoring before surgery and approximately 1 year after surgery.

Primary Outcome Measure

Change in Garmin Sleep Score [ Time Frame: Preoperative baseline and approximately 1 year postoperative ]

Central Contacts

Related Studies