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 (SNORE)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea Syndrome, Obstructive; Sleep Apnea Syndrome (OSAS)

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 Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Martin V.H. Rutten, Msc, MD; Phone Number: 28657 +31205669111; Email: m.v.rutten@amsterdamumc.nl
• Study Contact Backup: Name: Jeroen Hermanides, Prof. Dr.; Phone Number: 62533 +310205669111; Email: j.hermanides@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Amsterdam UMC location VUmc
    • Contact: Martin Rutten; Phone Number: +31 6 50075296; Email: m.v.rutten@amsterdamumc.nl
    • Contact: Luca den Tenter; Phone Number: 28657 +31 205669111; Email: l.m.dententer@amsterdamumc.nl
    • Contact: Martin Rutten
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • AmsterdamUMC, location AMC
      • Contact: Martin Rutten, Msc, MD; Phone Number: 28657 +31(0)205669111; Email: m.v.rutten@amsterdamumc.nl
      • Contact: Martin Rutten, Msc, MD; Phone Number: +31 (0)653326924; Email: m.v.rutten@amsterdamumc.nl
      • Contact: Martin Rutten, Msc, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI and Desaturations on night one and three after surgery	To compare the AHI and desaturations on night one and night three after surgery	from directly post operatively up untill the morning after the third night following surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturations post operatively	Assess the amount of patients with na increase of respiratory events (saturation <90%) later than 6 hours after surgery.	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.	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.	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.	Night one, two and three.
REM sleep and AHI	Correlation between REM Sleep and respiratory events measured as AHI	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.	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	from directly post-operatively to the morning after the third night.

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: VU University of Amsterdam; Amsterdam Medical Center (AMC)
• Investigators: Principal Investigator: Jeroen Hermanides, Prof. Dr., AmsterdamUMC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: OSA; obstructive sleep apnea; Post-surgical; AHI; REM sleep; PACU; OSAS; Desaturations; post-anesthesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Respiratory Tract Diseases; Disease; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Syndrome; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2024.0163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Study protocol, ICF (standard model) with SAP are available upon request as of now. (september 2024) Data will be available until 5 year after publishing.

IPD Sharing Access Criteria

Only the researchteam will have direct acces to the researchdata and specific patient data.

External requests will be evaluated by the principal investigator

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No