Obstructive Sleep ApneaOXYBARNCT06432933
Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery
A study testing No preventive oxygen therapy (2L) in people with Obstructive Sleep Apnea and Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity, Bariatric Surgery Candidate
- What is being tested?
- No preventive oxygen therapy (2L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Apr 2024to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergo primary bariatric surgery (RYGB or SG)
- Speak and read the Dutch language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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).
Read the 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.
- Being tested
- No preventive oxygen therapy (2L), Preventive oxygen therapy (2L) standard care
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.
| Study group | Role | What they receive |
|---|---|---|
| Without preventive oxygen therapy | Experimental | Not described Receives: Other: No preventive oxygen therapy (2L) |
| With preventive oxygentherapy | Active comparator | Not described Receives: Other: Preventive oxygen therapy (2L) standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First postoperative night
Secondary outcomes (24)
Complication rate
All complication will be scored and will be compared between both arms
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: First postoperative night
Mean saturation
Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Measured: 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
Measured: 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
Measured: First postoperative night
Percentage of saturation <90%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Measured: First postoperative night
Percentage of saturation <88%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Measured: First postoperative night
Percentage of saturation <85%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Measured: First postoperative night
Percentage of saturation <80%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Measured: First postoperative night
Percentage of saturation <70%
will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: First postoperative night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start9 Apr 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Hazebroek, Prof.dr., Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432933
- Sponsor's protocol ID
- 2023-2352
- Acronym
- OXYBAR
- Status last verified
- Jul 2025
- First submitted
- 3 Apr 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06432933
- Acronym / sponsor ID
- OXYBAR / 2023-2352
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without preventive oxygen therapy | Experimental | Other: No preventive oxygen therapy (2L) |
| With preventive oxygentherapy | Active comparator | Other: Preventive oxygen therapy (2L) standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergo primary bariatric surgery (RYGB or SG)
- Speak and read the Dutch language
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No preventive oxygen therapy (2L)Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery. | Other | Without preventive oxygen therapy |
| Preventive oxygen therapy (2L) standard careParticipants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care. | Other | With preventive oxygentherapy |
Primary outcome
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
24 secondary outcomes
Complication rate
Time frame: Until 30 days after surgery
The number of nursing interventions
Time frame: First postoperative night
Type of nursing interventions
Time frame: First postoperative night
Oxygen Desaturation Index (ODI)
Time frame: First postoperative night
AHI during Rapid Eye Movement (REM) sleep
Time frame: First postoperative night
Respiratory disturbance index (RDI)
Time frame: First postoperative night
Mean saturation
Time frame: First postoperative night
Mean saturation during desaturations,
Time frame: First postoperative night
Number of desaturations
Time frame: First postoperative night
Percentage of saturation <90%
Time frame: First postoperative night
Percentage of saturation <88%
Time frame: First postoperative night
Percentage of saturation <85%
Time frame: First postoperative night
Percentage of saturation <80%
Time frame: First postoperative night
Percentage of saturation <70%
Time frame: First postoperative night
Time (minutes) of saturation <90%
Time frame: First postoperative night
Time (minutes) of saturation <88%
Time frame: First postoperative night
Time (minutes) of saturation <85%
Time frame: First postoperative night
Time (minutes) of saturation <80%
Time frame: First postoperative night
Time (minutes) of saturation <70%
Time frame: First postoperative night
Total sleep time (minutes)
Time frame: First postoperative night
Percentage of REM sleep in total sleep time
Time frame: First postoperative night
Percentage of Deep sleep in total sleep time
Time frame: First postoperative night
Percentage of light sleep in total sleep time
Time frame: First postoperative night
Percentage of awake time
Time frame: First postoperative night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hazebroek, Prof.dr. principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No preventive oxygen therapy (2L) in people with Obstructive Sleep Apnea and Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: First postoperative night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.