NCT05608031

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

November 1, 2022

Last Update Submit

November 1, 2022

Conditions

Keywords

Laparoscopic sleeve gastrectomyPittsburgh sleep quality indexObesity

Outcome Measures

Primary Outcomes (2)

  • good sleep quality

    A PSQI global score above 5 indicates poor sleep quality.

    6 months

  • poor sleep quality

    A PSQI global score above 5 indicates poor sleep quality.

    6 months

Study Arms (1)

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

Interventions

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.

bariatric surgery

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients treated for sleep disorders have been excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Ümraniye, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ParasomniasObesity, MorbidObesity

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 7, 2022

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations