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

Sponsor

Umraniye Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05608031

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance Obesity, Severe Surgery	Other: Pittsburgh sleep quality index (PSQI) scale

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 Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

bariatric surgery

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.

Outcome Measures

Primary Outcome Measures

good sleep quality [6 months]
A PSQI global score above 5 indicates poor sleep quality.
poor sleep quality [6 months]
A PSQI global score above 5 indicates poor sleep quality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Umraniye Education and Research Hospital	Istanbul	Ümraniye	Turkey	34000

Sponsors and Collaborators

Umraniye Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatih Basak, Clinical Associate Professor, Umraniye Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05608031

Other Study ID Numbers:

Obesity-Sleep-Quality

First Posted:

Nov 7, 2022

Last Update Posted:

Nov 7, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fatih Basak, Clinical Associate Professor, Umraniye Education and Research Hospital

Laparoscopic sleeve gastrectomy

Pittsburgh sleep quality index

Obesity

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Obesity, Morbid

Study Results

No Results Posted as of Nov 7, 2022