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Sleep Evaluation Before and After Metabolic Surgery

NCT07693491 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Primary Metabolic Surgery

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.

Sponsors & Collaborators

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-01
Completion
2029-09-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07693491 on ClinicalTrials.gov