An interventional study of No preventive oxygen therapy (2L) and Preventive oxygen therapy (2L) standard care in Obstructive Sleep Apnea, Obesity and Bariatric Surgery Candidate, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Treatment
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).
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's enrollment of 153 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: No preventive oxygen therapy (2L)
Other: Preventive oxygen therapy (2L) standard care
Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.
Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.
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
Time frame: First postoperative night
Complication rate
All complication will be scored and will be compared between both arms
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First postoperative night
Mean saturation
Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time frame: 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
Time frame: 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
Time frame: First postoperative night
Percentage of saturation <90%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time frame: First postoperative night
Percentage of saturation <88%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time frame: First postoperative night
Percentage of saturation <85%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time frame: First postoperative night
Percentage of saturation <80%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time frame: First postoperative night
Percentage of saturation <70%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First postoperative night
Plan to share: No
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Rijnstate Hospital