Obstructive Sleep ApneaDAGBARNCT06452784
Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery
An observational study of Obstructive Sleep Apnea and Bariatric Surgery Candidate, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Bariatric Surgery Candidate, Same-day Discharge
- How many people
- 103 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 May 2024to 5 Jul 2025
- Phase
- Observational
- 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
Study population: Patients undergoing primary same-day discharge bariatric surgery, with exclusion of patients with treated OSA, patients using alpha blockers or professional drivers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index (AHI)
The AHI will be measured by the Watchpat One and compared between the different timepoints.
Measured: Measurements will take place 7 days before and 1 and 3 days after surgery
Secondary outcomes (17)
Oxygen Desaturation Index (ODI)
The ODI will be measured by the Watchpat One and compared between the different timepoints.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days
Total sleep time (minutes)
The total sleep time will be measured by the Watchpat One and compared between the different timepoints.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurements will take place 7 days before and 1 and 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start31 May 2024
- Primary completion5 Jul 2025
- Study completion5 Jul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Hazebroek, Professor, Principal investigator, Vitalys part of Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452784
- Sponsor's protocol ID
- 2024-2418
- Acronym
- DAGBAR
- Status last verified
- Jul 2025
- First submitted
- 5 Jun 2024
- Last updated
- 22 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery in Patients With Potentially Undiagnosed Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06452784
- Acronym / sponsor ID
- DAGBAR / 2024-2418
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 11 Jun 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary same-day discharge bariatric surgery, with exclusion of patients with treated OSA, patients using alpha blockers or professional drivers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea hypopnea index (AHI)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The AHI will be measured by the Watchpat One and compared between the different timepoints.
17 secondary outcomes
Oxygen Desaturation Index (ODI)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The AHI during rapid eye movement (sleep)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Respiratory disturbance index (RDI),
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of time with a saturation <90%
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Time of a saturation <90%
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Mean saturation
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Mean saturation during desaturations
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Number of desaturations
Time frame: 10 days
Total sleep time (minutes)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of total sleep in REM sleep
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Time in REM sleep (minutes)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of total sleep in deep sleep
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The time in deep sleep (minutes)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of total sleep in light sleep
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The time in light sleep (minutes)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
Percentage of awake time
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
The awake time (minutes)
Time frame: Measurements will take place 7 days before and 1 and 3 days after surgery
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 22 Jul 2025.
- Individual participant dataSharing planned: No
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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, Professor principal investigator
Vitalys part of Rijnstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Bariatric Surgery Candidate, 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 3 inclusion and 7 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 22 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: Measurements will take place 7 days before and 1 and 3 days after surgery). 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 22 Jul 2025.