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

NCT06586268 | Recruiting

• 1 other identifier: 2024.0163
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Apnea Syndrome, Obstructive; Sleep Apnea Syndrome (OSAS)

Keywords

OSAS; OSA; obstructive sleep apnea; Post-surgical; post-anesthesia; REM sleep; PACU; AHI; Desaturations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• VU University of Amsterdam: collaborator

Study Sites (2)

AmsterdamUMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Amsterdam UMC location VuMC

Amsterdam, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jeroen Hermanides, Prof. Dr.

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin V.H. Rutten, Msc, MD

CONTACT

+31205669111; m.v.rutten@amsterdamumc.nl

Jeroen Hermanides, Prof. Dr.

CONTACT

+310205669111; j.hermanides@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, MD

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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

Locations

NL (2)