NCT04731168

Brief Summary

Sleep apneic episodes increase after general anaesthesia up to the third postoperative night. A mandibular advancement device, called MAD, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. The objective of this randomized controlled trial is to determine whether a MAD reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. All patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (ResMed Embletta® system). This portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (SpO2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

January 25, 2021

Last Update Submit

November 20, 2023

Conditions

Peri-operative MedicineSleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Supine AHI

    Apnea-Hypopnea index in the supine position

    Postoperative night 1

Secondary Outcomes (7)

  • Global AHI

    Postoperative night 1

  • OAI

    Postoperative night 1

  • CAI

    Postoperative night 1

  • Hypopnea index

    Postoperative night 1

  • ODI

    Postoperative night 1

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

MAD

EXPERIMENTAL

Patients will have a mandibular advancement device during the first postoperative night

Device: Mandibular advancement device

Interventions

Mandibular advancement deviceDEVICE

Patients will have a mandibular advancement device during the first postoperative night

MAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- adult patient undergoing any lower limb surgery

You may not qualify if:

  • continuous positive airway pressure (CPAP) treatment for obstructive sleep apnoea,
  • presence of severe respiratory or cardiovascular disease
  • preoperative consumption of benzodiazepine,
  • chronic use of opioids \> 30 mg/day morphine equivalent
  • no tooth
  • patient known for malignant hyperthermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program director of regional anaesthesia

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 29, 2021

Study Start

February 1, 2021

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

CH(1)