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NCT05608031 Clinical Trial

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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05608031
Other study ID # Obesity-Sleep-Quality
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information
Verified date November 2022
Source Umraniye Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Umraniye Education and Research Hospital Istanbul Ümraniye

Sponsors (1)
Lead Sponsor Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary good sleep quality A PSQI global score above 5 indicates poor sleep quality. 6 months
Primary poor sleep quality A PSQI global score above 5 indicates poor sleep quality. 6 months
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