NCT07693491

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
37mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 3, 2026

Last Update Submit

July 9, 2026

Conditions

Obesity & OverweightObesity & Overweight SleepSleepMetabolic Surgery

Keywords

Sleep QualityGarmin Sleep ScoreWearable devicesHome-based sleep monitoringPhotoplethysmographyMetabolic bariatric surgeryWeight lossPittsburgh Sleep Quality IndexSleep regularity

Outcome Measures

Primary Outcomes (1)

  • Change in Garmin Sleep Score

    Change in objective sleep quality from preoperative baseline to approximately 1 year after metabolic surgery, measured using the Garmin Sleep Score. The Garmin Sleep Score is a device-derived composite sleep quality score ranging from 0 to 100, with higher scores indicating better sleep quality. It is based on sleep-related parameters including sleep duration, sleep stages, restlessness, and related metrics.

    Preoperative baseline and approximately 1 year postoperative

Study Arms (1)

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.

Procedure: Primary Metabolic Surgery

Interventions

Primary Metabolic SurgeryPROCEDURE

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.

Patients Undergoing Primary Metabolic Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

MeSH Terms

Conditions

ObesityOverweightSleep Initiation and Maintenance DisordersWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBody Weight Changes

Central Study Contacts

Ephrahim E Jerry, MD

CONTACT

+31634250807ephrahim.jerry@catharinaziekenhuis.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and PhD Candidate

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because of participant privacy, GDPR requirements, and the limited sample size of this single-center study. Study data will be stored as coded/pseudonymized data on secure, access-restricted systems at Catharina Hospital Eindhoven. Only authorized members of the research team will have access to the study data. Technical device data may be shared with SmartQare only as described in the study protocol and without directly identifiable participant information.

Locations

NL(1)