Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery (OXYBAR)

Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery

The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary.

The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy.

Methods:

Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B:

Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

Study Overview

• Status: Completed
• Conditions: Obesity; Obstructive Sleep Apnea; Bariatric Surgery Candidate
• Intervention / Treatment: Other: No preventive oxygen therapy (2L); Other: Preventive oxygen therapy (2L) standard care

Detailed Description

Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed.

Objective: The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients

Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy.

Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

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

Description

Inclusion Criteria:

• Undergo primary bariatric surgery (RYGB or SG)
• Speak and read the Dutch language

Exclusion Criteria:

• Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
• Same-day discharge after bariatric surgery
• Diagnosed OSA with treatment (CPAP, oral appliances)
• Professional drivers
• Use of alpha blockers
• Unable to speak or read the Dutch language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Without preventive oxygen therapy	Other: No preventive oxygen therapy (2L); Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.
Active Comparator: With preventive oxygentherapy	Other: Preventive oxygen therapy (2L) standard care; Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI)	AHI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms, the higher the AHI the more severe the sleep apnea	First postoperative night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	All complication will be scored and will be compared between both arms	Until 30 days after surgery
The number of nursing interventions	Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms	First postoperative night
Type of nursing interventions	e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms.	First postoperative night
Oxygen Desaturation Index (ODI)	ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
AHI during Rapid Eye Movement (REM) sleep	AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Respiratory disturbance index (RDI)	RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Mean saturation	Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Mean saturation during desaturations,	Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Number of desaturations	Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of saturation <90%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of saturation <88%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of saturation <85%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of saturation <80%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of saturation <70%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Time (minutes) of saturation <90%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Time (minutes) of saturation <88%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Time (minutes) of saturation <85%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Time (minutes) of saturation <80%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Time (minutes) of saturation <70%	will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Total sleep time (minutes)	Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of REM sleep in total sleep time	Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of Deep sleep in total sleep time	Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of light sleep in total sleep time	Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night
Percentage of awake time	Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms	First postoperative night

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Eric Hazebroek, Prof.dr., Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 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: 2023-2352

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