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Completed

NCT Number: NCT06432933

Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy 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).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Bariatric Surgery Candidate Body Weight Dyssomnias Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitalys

Elst, 6662 NC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No preventive oxygen therapy (2L)

Other

Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.

Preventive oxygen therapy (2L) standard care

Other

Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: First postoperative night

    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

Secondary outcomes

  1. Complication rate

    Time frame: Until 30 days after surgery

    All complication will be scored and will be compared between both arms

  2. The number of nursing interventions

    Time frame: First postoperative night

    Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms

  3. Type of nursing interventions

    Time frame: First postoperative night

    e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms.

  4. Oxygen Desaturation Index (ODI)

    Time frame: First postoperative night

    ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  5. AHI during Rapid Eye Movement (REM) sleep

    Time frame: First postoperative night

    AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  6. Respiratory disturbance index (RDI)

    Time frame: First postoperative night

    RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  7. Mean saturation

    Time frame: First postoperative night

    Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  8. Mean saturation during desaturations,

    Time frame: First postoperative night

    Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  9. Number of desaturations

    Time frame: First postoperative night

    Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  10. Percentage of saturation <90%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  11. Percentage of saturation <88%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  12. Percentage of saturation <85%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  13. Percentage of saturation <80%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  14. Percentage of saturation <70%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  15. Time (minutes) of saturation <90%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  16. Time (minutes) of saturation <88%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  17. Time (minutes) of saturation <85%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  18. Time (minutes) of saturation <80%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  19. Time (minutes) of saturation <70%

    Time frame: First postoperative night

    will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  20. Total sleep time (minutes)

    Time frame: First postoperative night

    Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  21. Percentage of REM sleep in total sleep time

    Time frame: First postoperative night

    Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  22. Percentage of Deep sleep in total sleep time

    Time frame: First postoperative night

    Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  23. Percentage of light sleep in total sleep time

    Time frame: First postoperative night

    Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

  24. Percentage of awake time

    Time frame: First postoperative night

    Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Acronym: OXYBAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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