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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

35 Participants
are grouped into 1 trial group
Group A: Patients scheduled for elective surgery with a diagnosis of obstructive sleep apnea (OSA)

Trial outcomes

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

Time frame
from directly post operatively up untill the morning after the third night following surgery.

Secondary outcomes

1

Desaturations post operatively

Assess the amount of patients with na increase of respiratory events (saturation \<90%) later than 6 hours after surgery.

Time frame
The first six hours after surgery
2

AHI directly post-operatively

compare the difference between AHI and desaturations in the first six hours after surgery to the first night after surgery.

Time frame
directly post-operatively up untill the next morning (max 24 hours)
3

Changes in total REM sleep

Changes in total REM sleep comparing night 1,2 and 3.

Time frame
The first three nights following surgery
4

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.

Time frame
Night one, two and three.

Other outcomes

Sponsors and contacts

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