The SNORE-trial: Postoperative REM-Sleep Disturbance in Obstructive Sleep-apnea Patients and the Relation with AH-index
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- AHI and Desaturations on night one and three after surgery
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Desaturations post operatively(The first six hours after surgery)
- AHI directly post-operatively(directly post-operatively up untill the next morning (max 24 hours))
- Changes in total REM sleep(The first three nights following surgery)
- Changes in AHI, REM-AHI and desaturations over time(Night one, two and three.)
- REM sleep and AHI(From directly post-operatively up untill the morning after the third night.)
- Comparison of patients with treatment and patients without treatment(DIrectly post-operatively up untill the morning after night three)
- Morfine and AHI/desaturations(from directly post-operatively to the morning after the third night.)
Investigators
Martin Rutten
MSc, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)