Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586268
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The SNORE-trial Postoperative REM-Sleep Disturbance in Obstructive Sleep-apnea Patients and the Relation with AH-index
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SNORE
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
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 08 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 005 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 15 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
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 08 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 005 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 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None