Sleep Apnea Syndrome, ObstructiveSNORENCT06586268
The SNORE-trial: Analysis of Alterations in Sleep Stages Following Anesthesia and Their Relation to the Severity of Obstructive Sleep Apnea in the First 3 Nights After Surgery
An observational study of Sleep Apnea Syndrome, Obstructive and Sleep Apnea Syndrome (OSAS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
The goal of this observational study is to learn about the relationship between sleep alterations following anesthesia and their relationship to a potential increase of obstructive sleep apnea (OSA) severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome, Obstructive, Sleep Apnea Syndrome (OSAS)
- How many people
- 35 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2024to Aug 2025
- How long will I take part?
- 3 Days
- 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 scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days
Who may be able to join
- Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days
- Patients with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) are considered patients with treatment for OSA
- Patients ≥ 18 years
- Dutch or English speaking
- Willing and able to sign consent for re-use of care data
Who cannot join
- Patients \< 18 years
- Not speaking Dutch or English
- Patients who do not sign consent for re-use of care data
- Surgery scheduled in day case or with an expected discharge before the third night after surgery
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
AmsterdamUMC, location AMC
Amsterdam, North Holland, 1105 AZ
Martin Rutten, Msc, MD, +31(0)205669111 ext. 28657, m.v.rutten@amsterdamumc.nl
Martin Rutten, Msc, MD, +31 (0)653326924, m.v.rutten@amsterdamumc.nl
- Recruiting
Amsterdam UMC location VuMC
Amsterdam, 1081 HV
Martin Rutten, +31 6 50075296, m.v.rutten@amsterdamumc.nl
Luca den Tenter, +31 205669111 ext. 28657, l.m.dententer@amsterdamumc.nl
About this study
Official title: The SNORE-trial: Postoperative REM-Sleep Disturbance iN Obstructive Sleep-apnea Patients and the Relation With AH-index
The goal of this observational study is to learn about the relationship between sleep alterations following anesthesia and their relationship to a potential increase of obstructive sleep apnea (OSA) severity.
Our main question is: Is there an increased severity of OSA on the third post-operative night compared to the first post-operative night and does this have a relation with REM sleep?
Participants enrolled in this research are all diagnosed with OSA, with or without treament. All participants will be asked to wear a watchlike device called WATCHPAT to identify sleep paterns and register apneic (no breathing) and hypopneic (insufficient breathing) incidents. We ask our participants to wear this device for 8-10 hours a night when they are a sleep.
Read the detailed description
The study is a prospective, observational, single center cohort study on electively scheduled adult surgical patients at the Amsterdam UMC, Amsterdam, The Netherlands.
Patients eligible for inclusion will be identified at the pre-operative screening at the outpatient clinic and contacted and included prior to the day of surgery.
Patients will sign an informed consent. Alternatively patients will be identified by an electronic algoritm which will analyse the next weeks elective surgery list. the algorithm analyzes for sleap apnea; in the patient problem list in their electronic patient file. Patients that have not been identified at the outpatient clinic will be able to be identified as eligible for inclusion via this route.
Measurement will start post-operatively at the recovery ward. All data will be registered with a non-invasive device, the WatchPAT (ZOLL medical). This device will measure apneic and hypopneic incidents, reported as apneu-hypopneu index (AHI) and vital signs such as blood pressure, heart rate and oxygen saturation. In addition the Watchpat will register REM-sleep via actigrapy. Other patient characteristics and demographics will be retrieved from the electronic patient file (EPIC).
These measurements will be started within 30 minutes of arriving at the recovery on the day of surgery continuing on into the first night at the PACU unit. On night 2 and 3 post-operatively participants will be asked to wear the device on the ward when going to sleep for the night. measurement period at the ward will be 8-10 hours.
For results on our primary outcome:
difference in mean of AHI and desaturations on night one compared to night three.
We aimed to detect a difference in mean of an AHI of 0.8 in a design with 3 repeated measurements when assuming a standard deviation of 2 and a very conservative between level correlation of 0. In order to detect a similar difference with a power of 80% and a significance level of 0.05, assuming a drop-out rate of 5%, we will need a sample size of 35 patients.
When patients are lost to follow up, or have incomplete measurements, defined as no functional data on sleep, AHI and desaturations in night 1 or night 3. Where a sleep time of 1,5 hours a night is minimally needed for complete calculations on AHI.
We will use descriptive statistics to present the characteristics of patients, using mean with standard deviation, or median with interquartile range for continuous data and as absolute frequencies with proportions for categorical data. The main outcome measure will be compared using a paired t-test. Correlations will be calculated using Pearsons correlation coefficient.
- Keywords
- OSAS, OSA, obstructive sleep apnea, Post-surgical, post-anesthesia, REM sleep, PACU, AHI, Desaturations
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
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 |
|---|---|---|
| Patients scheduled for elective surgery with a diagnosis of obstructive sleep apnea (OSA) | * Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment * Patients with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) are considered patients with treatment for OSA * Patients ≥ 18 years * Dutch or English speaking * Willing and able to sign consent for re-use of care data |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI and Desaturations on night one and three after surgery
To compare the AHI and desaturations on night one and night three after surgery
Measured: from directly post operatively up untill the morning after the third night following surgery.
Secondary outcomes (7)
Desaturations post operatively
Assess the amount of patients with na increase of respiratory events (saturation \<90%) later than 6 hours after surgery.
Measured: The first six hours after surgery
AHI directly post-operatively
compare the difference between AHI and desaturations in the first six hours after surgery to the first night after surgery.
Measured: directly post-operatively up untill the next morning (max 24 hours)
Changes in total REM sleep
Changes in total REM sleep comparing night 1,2 and 3.
Measured: The first three nights following surgery
Changes in AHI, REM-AHI and desaturations over time
To analyze the changes over time in AHI, REM-AHI, (respiratory events related tot REM-sleep cycle) and desaturations.
Measured: Night one, two and three.
REM sleep and AHI
Correlation between REM Sleep and respiratory events measured as AHI
Measured: From directly post-operatively up untill the morning after the third night.
Comparison of patients with treatment and patients without treatment
Comparing AHI and desaturations between patients with either a MRA or CPAP treatment to those without any form of treatment or other treatment than MRA and CPAP.
Measured: DIrectly post-operatively up untill the morning after night three
Morfine and AHI/desaturations
Compare respiratory events measured as AHI or desaturations compared to opioid consumption, measured as morphine equivalents.
identifying different time-frames.
- the first 6 hours after surgery
- the first night after surgery (excluding the first six hours)
- night 2 and night 3 after surgery. also identifying different modalities if applicable.
- IV (patient controled and nurse controled)
- oral
Measured: from directly post-operatively to the morning after the third night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndrome, ObstructiveStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- 35 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Principal investigator, Martin Rutten, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jeroen Hermanides, Prof. Dr., Principal investigator, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586268
- Sponsor's protocol ID
- 2024.0163
- Acronym
- SNORE
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study-protocol: will be available upon request SAP ,ICV, CSR will all be able on request. Data will be anonymized when data shared is patient specific. There is no analytical code involved in our study. therefore this will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SNORE-trial: Postoperative REM-Sleep Disturbance iN Obstructive Sleep-apnea Patients and the Relation With AH-index
- ClinicalTrials.gov ID
- NCT06586268
- Acronym / sponsor ID
- SNORE / 2024.0163
- Keywords
- OSAS, OSA, obstructive sleep apnea, Post-surgical, post-anesthesia, REM sleep, PACU, AHI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 19 Sep 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 goal of this observational study is to learn about the relationship between sleep alterations following anesthesia and their relationship to a potential increase of obstructive sleep apnea (OSA) severity.
Our main question is: Is there an increased severity of OSA on the third post-operative night compared to the first post-operative night and does this have a relation with REM sleep?
Participants enrolled in this research are all diagnosed with OSA, with or without treament. All participants will be asked to wear a watchlike device called WATCHPAT to identify sleep paterns and register apneic (no breathing) and hypopneic (insufficient breathing) incidents. We ask our participants to wear this device for 8-10 hours a night when they are a sleep.
Detailed description
The study is a prospective, observational, single center cohort study on electively scheduled adult surgical patients at the Amsterdam UMC, Amsterdam, The Netherlands.
Patients eligible for inclusion will be identified at the pre-operative screening at the outpatient clinic and contacted and included prior to the day of surgery.
Patients will sign an informed consent. Alternatively patients will be identified by an electronic algoritm which will analyse the next weeks elective surgery list. the algorithm analyzes for sleap apnea; in the patient problem list in their electronic patient file. Patients that have not been identified at the outpatient clinic will be able to be identified as eligible for inclusion via this route.
Measurement will start post-operatively at the recovery ward. All data will be registered with a non-invasive device, the WatchPAT (ZOLL medical). This device will measure apneic and hypopneic incidents, reported as apneu-hypopneu index (AHI) and vital signs such as blood pressure, heart rate and oxygen saturation. In addition the Watchpat will register REM-sleep via actigrapy. Other patient characteristics and demographics will be retrieved from the electronic patient file (EPIC).
These measurements will be started within 30 minutes of arriving at the recovery on the day of surgery continuing on into the first night at the PACU unit. On night 2 and 3 post-operatively participants will be asked to wear the device on the ward when going to sleep for the night. measurement period at the ward will be 8-10 hours.
For results on our primary outcome:
difference in mean of AHI and desaturations on night one compared to night three.
We aimed to detect a difference in mean of an AHI of 0.8 in a design with 3 repeated measurements when assuming a standard deviation of 2 and a very conservative between level correlation of 0. In order to detect a similar difference with a power of 80% and a significance level of 0.05, assuming a drop-out rate of 5%, we will need a sample size of 35 patients.
When patients are lost to follow up, or have incomplete measurements, defined as no functional data on sleep, AHI and desaturations in night 1 or night 3. Where a sleep time of 1,5 hours a night is minimally needed for complete calculations on AHI.
We will use descriptive statistics to present the characteristics of patients, using mean with standard deviation, or median with interquartile range for continuous data and as absolute frequencies with proportions for categorical data. The main outcome measure will be compared using a paired t-test. Correlations will be calculated using Pearsons correlation coefficient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for elective surgery with a diagnosis of obstructive sleep apnea (OSA) | – | –* Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment * Patients with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) are considered patients with treatment for OSA * Patients ≥ 18 years * Dutch or English speaking * Willing and able to sign consent for re-use of care data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days
Key inclusion criteria (5 listed)
- Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days
- Patients with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) are considered patients with treatment for OSA
- Patients ≥ 18 years
- Dutch or English speaking
- Willing and able to sign consent for re-use of care data
Key exclusion criteria (4 listed)
- Patients \< 18 years
- Not speaking Dutch or English
- Patients who do not sign consent for re-use of care data
- Surgery scheduled in day case or with an expected discharge before the third night after surgery
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
AHI and Desaturations on night one and three after surgery
Time frame: from directly post operatively up untill the morning after the third night following surgery.
To compare the AHI and desaturations on night one and night three after surgery
7 secondary outcomes
Desaturations post operatively
Time frame: The first six hours after surgery
AHI directly post-operatively
Time frame: directly post-operatively up untill the next morning (max 24 hours)
Changes in total REM sleep
Time frame: The first three nights following surgery
Changes in AHI, REM-AHI and desaturations over time
Time frame: Night one, two and three.
REM sleep and AHI
Time frame: From directly post-operatively up untill the morning after the third night.
Comparison of patients with treatment and patients without treatment
Time frame: DIrectly post-operatively up untill the morning after night three
Morfine and AHI/desaturations
Time frame: from directly post-operatively to the morning after the third night.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes. Study-protocol: will be available upon request SAP ,ICV, CSR will all be able on request. Data will be anonymized when data shared is patient specific. There is no analytical code involved in our study. therefore this will not be shared.
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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.
Jeroen Hermanides, Prof. Dr. principal investigator
AmsterdamUMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndrome, Obstructive and Sleep Apnea Syndrome (OSAS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin V.H. Rutten, Msc, MD (+31205669111 ext. 28657, m.v.rutten@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI and Desaturations on night one and three after surgery (time frame: from directly post operatively up untill the morning after the third night following 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 29 Jan 2025.