Can Sleep Apnea Screening Questionnaire Predict Adverse Events in Endoscopic Studies

NCT03436381 | Completed

• 1 other identifier: FLA 17-104
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators hypothesize that the obese population (BMI ≥30 kg/m2) who might be at higher risk for obstructive sleep apnea (OSA), carries a higher risk of endoscopy associated adverse events. The primary aim of our study is to determine predictors of endoscopy associated adverse events (airway maneuvers and sedation related complications) in the obese population including the use of the STOP-BANG questionnaire (SBQ) and Epworth Sleepiness Scale (ESS). A secondary aim is to determine the impact of referral to sleep medicine clinic and home sleep test ordered from the gastroenterologist if patient was found to be high risk for OSA by the use of validated questionnaires such as SBQ and ESS.

Conditions

Sleep Apnea; Adverse Event

Outcome Measures

Primary Outcomes (1)

• Predictors of endoscopy associated adverse events

  Determine predictors of endoscopy associated adverse events (airway maneuvers and sedation related complications) in the obese population including the use of the STOP-BANG questionnaires and Epworth sleepiness scale

  2/9/2018 - 2/18/2019

Secondary Outcomes (1)

• Impact of referral to sleep medicine clinic and home sleep test

  2/9/2018 - 2/18/2019

Study Arms (1)

Overweight and obese patients

Patient undergoing elective upper endoscopy or colonoscopy, body mass index equal or greater than 25 kg/m2.

Other: Questionaire

Interventions

Questionaire OTHER

We will provide two sleep apnea screening questionnaire, Stop-bang questionnaire and Epworth sleepiness scale

Overweight and obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient presenting to endoscopy unit for routine esophagogastrodudenoscopy, colonoscopy or both who have a BMI equal or greater than 25 kg/m2.

You may qualify if:

• Undergoing elective upper endoscopy or colonoscopy
• Body mass index equal or greater than 25 kg/m2

You may not qualify if:

• Patients \<18 years of age
• pregnant women
• lung disease requiring oxygen
• oxygen saturation less or equal to 90% at the beginning of endoscopy
• BMI \<25
• ASA ≥4
• Inability to obtain consent

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Fernando Castro, M.D

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: February 9, 2018
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: October 22, 2025

Record last verified: 2019-12

Locations

US (1)