6th Month EWL% After Sleeve Gastrectomy to Get a Better Sleep Quality

November 1, 2022 updated by: Fatih Basak, Umraniye Education and Research Hospital

Which Value of 6th Month EWL% After Sleeve Gastrectomy is Needed to Get a Better Sleep Quality?

Obesity, caused by caloric intake over output, has become a global health problem. The relationship between sleep and obesity is widely discussed in the literature. Little is known regarding the compliance of sleep quality and patients' weight loss. This study aimed to review how sleep quality is affected by bariatric surgery, examine whether compliance with sleep quality can be predicted after bariatric surgery, and assess its correlation with excess weight loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A cross-sectional study was conducted among patients that underwent bariatric surgery (laparoscopic sleeve gastrectomy). Sleep quality was assessed using the Pittsburgh sleep quality index (PSQI) scale preoperatively and at the 6th postoperative month. Survey data were recorded and PSQI scores were calculated. A PSQI global score above 5 indicates poor sleep quality. The participants were divided into two groups good sleep quality and poor sleep quality. Descriptive statistics and Spearman correlations were applied. Logistic regression analysis was performed to predict sleep quality.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ümraniye
      • Istanbul, Ümraniye, Turkey, 34000
        • Umraniye Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Demographic parameters of the patients, preoperative and follow-up weight, body mass index (BMI), percentage of excess weight loss (EWL%), and percentage of excess BMI loss (EBMI%) were noted. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was applied to all patients preoperatively. Survey data were recorded and PSQI scores were calculated. Appropriate nutrition and physical activity programs were administered to all patients postoperatively under the control of a nutritionist.

Description

Inclusion Criteria:

Patients who underwent LSG for morbid obesity after being considered suitable for bariatric surgery by multidisciplinary evaluation were included in this study. Patients with aged 18-65 years, BMI > 40 and BMI > 35 and comorbid disease were included.

Exclusion Criteria:

Patients treated for sleep disorders have been excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bariatric surgery
A cross-sectional study was conducted among patients that underwent bariatric surgery (laparoscopic sleeve gastrectomy). Sleep quality was assessed using the Pittsburgh sleep quality index (PSQI) scale preoperatively and at the 6th postoperative month.
Other: Pittsburgh sleep quality index (PSQI) scale
Pittsburgh Sleep Quality Index (PSQI) (6), a self-report questionnaire comprising seven component scores (subjective sleep quality, sleep latency, duration of sleep, sleep efficiency habits, sleep disturbances, use of sleeping medication, and daytime dysfunction), was used to evaluate sleep quality over the last month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
good sleep quality
Time Frame: 6 months
A PSQI global score above 5 indicates poor sleep quality.
6 months
poor sleep quality
Time Frame: 6 months
A PSQI global score above 5 indicates poor sleep quality.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umraniye Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity-Sleep-Quality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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