Peri-operative MedicinePoMADNCT04731168
Prevention of Sleep Apnea After General Anaesthesia With a MAD
A study testing Mandibular advancement device in people with Peri-operative Medicine and Sleep Apnea, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-operative Medicine, Sleep Apnea
- What is being tested?
- Mandibular advancement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient undergoing any lower limb surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial
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.
- Conditions
- Peri-operative Medicine, Sleep Apnea
- Being tested
- Mandibular advancement device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement deviceDevice
Patients will have a mandibular advancement device during the first postoperative night
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| MAD | Experimental | Patients will have a mandibular advancement device during the first postoperative night Receives: Device: Mandibular advancement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supine AHI
Apnea-Hypopnea index in the supine position
Measured: Postoperative night 1
Secondary outcomes (7)
Global AHI
Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording
Measured: Postoperative night 1
OAI
Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording
Measured: Postoperative night 1
CAI
Central apnoea index: the number of apnoea from a central origin per hour of recording
Measured: Postoperative night 1
Hypopnea index
Hypopnea index: the number of hypopnoea per hour of recording
Measured: Postoperative night 1
ODI
Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep.
Measured: Postoperative night 1
Respiratory Rate
Respiratory Rate
Measured: Postoperative night 1
Percentage of supine time
Percentage of supine time
Measured: Postoperative night 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Feb 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-operative MedicineStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731168
- Sponsor's protocol ID
- 2020-01177
- Acronym
- PoMAD
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04731168
- Acronym / sponsor ID
- PoMAD / 2020-01177
- Conditions
- Peri-operative Medicine, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| MAD | Experimental | Device: Mandibular advancement devicePatients will have a mandibular advancement device during the first postoperative night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient undergoing any lower limb surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular advancement devicePatients will have a mandibular advancement device during the first postoperative night | Device | MAD |
Primary outcome
Supine AHI
Time frame: Postoperative night 1
Apnea-Hypopnea index in the supine position
7 secondary outcomes
Global AHI
Time frame: Postoperative night 1
OAI
Time frame: Postoperative night 1
CAI
Time frame: Postoperative night 1
Hypopnea index
Time frame: Postoperative night 1
ODI
Time frame: Postoperative night 1
Respiratory Rate
Time frame: Postoperative night 1
Percentage of supine time
Time frame: Postoperative night 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement device in people with Peri-operative Medicine and Sleep Apnea, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supine AHI (time frame: Postoperative night 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.