Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery (DAGBAR)

Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea

A recent development is same-day discharge in bariatric surgery, this seems to be safe if proper discharge criteria are used. However, yet there is no guideline for these discharge criteria, including for patients with (potential) Obstructive Sleep Apnea (OSA). To establish proper discharge criteria concerning OSA more information about (changes in) OSA during the first days after bariatric surgery is required.

The aim of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA.

Methods: Patients (n=60) will undergo a Home Sleep Apnea test , pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Bariatric Surgery Candidate; Same-day Discharge

Detailed Description

Rationale:

Bariatric surgery is a highly effective and sustainable treatment against obesity. Recently there has been a trend towards Same-Day Discharge (SDD) bariatric surgery. SDD bariatric surgery has proven to be safe, when proper discharge criteria are used. However, there is no consensus or guideline for discharge criteria for SDD bariatric surgery. In particular, discharge criteria for patients with obstructive sleep apnea (OSA) diverge between hospitals. In some, but not all hospitals, having (untreated) OSA is a contra-indication for SDD bariatric surgery.

In Rijnstate hospital, bariatric patients are not routinely tested for OSA preoperatively, meaning that they potentially have undiagnosed OSA. Having potentially undiagnosed OSA, is not a contra-indication for SDD bariatric surgery in Rijnstate hospital. Hospitals could be hesitant for SDD bariatric surgery in patients with OSA, because it is known that the apnea hypopnea index (AHI) increases postoperatively. In a population without obesity, the highest postoperative AHI was found during the third postoperative night. During this third postoperative night, patients with a normal postoperative course will already sleep at home, both after inpatient and SDD bariatric surgery. This raises the question whether having (untreated) OSA should be a contra-indication for SDD bariatric surgery. However, it is unknown if the same postoperative changes in AHI and sleep architecture occur in patients undergoing bariatric surgery. Objective: The primary objective of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA. The secondary objective of this study is to compare postoperative AHI changes between patients with a pre-operative AHI of 0-14 or ≥15. The tertiary objective of this study is to describe and compare pre- and postoperative sleep architecture.

Study design:

This is a prospective observational study. AHI and sleep architecture will be assessed and compared before and after Same-Day discharge (SDD) bariatric surgery during the first and third postoperative night with Home Sleep Apnea Tests.

Study population: Patients scheduled for primary SDD bariatric surgery without treated OSA

Main study parameters/endpoints: Primary endpoint is AHI. Secondary and tertiary endpoints are 30 days complications rate, and parameters for sleep architecture and sleep related breathing.

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Netherlands
  • Elst, Netherlands, 6662 NC
    • Vitalys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing primary same-day discharge bariatric surgery, with exclusion of patients with treated OSA, patients using alpha blockers or professional drivers

Description

Inclusion Criteria:

• Undergo primary bariatric surgery (Roux and y gastric bypass or sleeve gastrectomy)
• Eligible for same-day discharge
• In possession and able to use a smartphone

Exclusion Criteria:

• Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
• Not eligible for same-day discharge
• Diagnosed OSA with treatment (CPAP, oral appliances)
• Professional drivers
• Use of alpha blockers
• Unable to speak or read the Dutch language
• Not in possession or not able to use a smartphone

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All study participants; Alle study participants will receive standard of care. For this study participants will complete two short questionnaires (the STOPBANG and ESS) and will undergo three home sleep apnea tests with the WatchPat one. These will be performed during the night seven days prior to surgery and during night one and three after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea hypopnea index (AHI)	The AHI will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Desaturation Index (ODI)	The ODI will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
The AHI during rapid eye movement (sleep)	The AHI during REM sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Respiratory disturbance index (RDI),	The RDI will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of time with a saturation <90%	The percentage of time with a saturation <90% will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Time of a saturation <90%	Time of a saturation <90% will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Mean saturation	Mean saturation will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Mean saturation during desaturations	Mean desaturation during desaturations will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Number of desaturations	The number of desaturations will be measured by the Watchpat One and compared between the different timepoints.	10 days
Total sleep time (minutes)	The total sleep time will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of total sleep in REM sleep	The percentage of REM sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Time in REM sleep (minutes)	The time in REM sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of total sleep in deep sleep	The percentage of deep sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
The time in deep sleep (minutes)	The time in deep sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of total sleep in light sleep	The percentage of light sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
The time in light sleep (minutes)	The time in light sleep will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of awake time	The percentage of awake time will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery
The awake time (minutes)	The awake time will be measured by the Watchpat One and compared between the different timepoints.	Measurements will take place 7 days before and 1 and 3 days after surgery

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Eric Hazebroek, Professor, Vitalys part of Rijnstate

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): July 5, 2025
• Study Completion (Actual): July 5, 2025

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2024-2418

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