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Sleep Impact

Influence of self-reported sleep complaints on metabolic surgery trajectory - Influence of self-reported sleep complaints on metabolic surgery trajectory

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON61266
Enrollment
3000
Registered
2026-05-28
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe obesity

Interventions

There is no investigational product or intervention. The study uses only existing routinely collected healthcare data from the electronic health record and preoperative screening questionnaires. No ad

Sponsors

Catharina Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Adult patients who underwent preoperative screening for metabolic/bariatric surgery at Catharina Hospital Eindhoven. Patients must have completed the standard preoperative screening questionnaires, and information must be available on the screening item regarding self-reported sleep problems negatively affecting the quality of night-time rest. Both patients who were ultimately eligible and not eligible for metabolic surgery may be included, provided that the required screening data are available.

Exclusion criteria

Exclusion criteria: Patients will be excluded if the response to the sleep complaint screening item is missing, if insufficient data linkage prevents analysis of the primary outcome, or if an objection to the use of routinely collected clinical data for scientific research has been registered according to hospital policy.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the prevalence of self-reported sleep complaints during preoperative screening for metabolic/bariatric surgery. Sleep complaints are defined using the routinely collected screening item regarding sleep problems negatively affecting the quality of night-time rest.As this item is not a validated sleep questionnaire, it will not be used to diagnose insomnia, obstructive sleep apnea, or any other clinical sleep disorder. The outcome will be interpreted only as a self-reported screening variable.

Secondary

MeasureTime frame
Secondary outcomes include associations between self-reported sleep complaints and predefined preoperative characteristics and screening outcomes, including age, sex, BMI, educational level, lifestyle factors, SQ-48 psychological symptom scores, quality of life measured with the Obesity Module of the BODY-Q, and multidisciplinary team decision regarding eligibility for metabolic surgery.Exploratory postoperative outcomes include percentage total weight loss (%TWL) at 1, 3, and 5 years after surgery, insufficient weight loss defined as <25% TWL, and weight recurrence defined as a 30% increase in weight from postoperative nadir weight.

Countries

Netherlands

Contacts

Public ContactE.E. Jerry

Catharina Ziekenhuis

ephrahim.jerry@catharinaziekenhuis.nl+31634250807

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026