OSA - Obstructive Sleep ApneaBioMADNCT07845331
BioMAD - A Non-inferiority Study
A study testing BioMAD in people with OSA - Obstructive Sleep Apnea, run by University of Lausanne Hospitals.
Trial summary
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- What is being tested?
- BioMAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (≥ 18 years) with diagnosis of obstructive sleep apnea (AHI ≥ 5/h).
- Current use of a ResMed or SomnoMed MAD for at least 3 months with reported adherence ≥ 4 hours/night.
- Ability and willingness to stop using the current MAD for a two-week wash-out period.
- Agrees to be informed on incidental findings
- Capable of giving informed consent.
Who cannot join
- Predominant central sleep apnea.
- Known temporo-mandibular joint disorders or significant dental conditions that preclude MAD use.
- Recent dental surgery (< 1 month) or planned during the investigation.
- Known pregnancy, breastfeeding or planning pregnancy during the study;
- Professional drivers or occupations requiring constant vigilance (due to risk of increased sleepiness during wash-out).
- Participation in another interventional trial or use of medications affecting sleep (sedative/hypnotic agents, opioids, muscle relaxants).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effectiveness of a New Mandibular Advancement Device (BioMAD) in the Treatment of Obstructive Sleep Apnea
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea.
Read the detailed description
The severity of OSA and associated symptoms will be assessed with the patients' usual mandibular devive (MAD), with no treatment (after a wash-out period), and with the new treatment (BioMAD)
- Conditions
- OSA - Obstructive Sleep Apnea
- Being tested
- BioMAD
- Keywords
- osa, MAD
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMADDevice
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| single arm | Active comparator | The patients will be recorded with their usual MAD Device, after a 2 week wash out period and under the new BioMAD device Receives: Device: BioMAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
Number of apneas and hypopneas per hour of sleep measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD.
Measured: Baseline, Day 15, Day 30
Secondary outcomes (4)
The hypoxic burden
The sum of oxygen drops following apneas and hypopneas in %/min/h measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD
Measured: Baseline, Day 15, Day 30
Sleep efficiency and EEG-based sleep microstructure metrics
Assessment of sleep efficiency (TST/time in bed) and EEG based sleep microstructure analysed by FFT measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD
Measured: Baseline, Day 15, Day 30
Subjective daytime sleepiness
Measured using the Epworth sleepiness scale
Measured: Baseline, Day 15, Day 30
Patients reported outcome measures (PROMS)
Patient-Reported Outcomes Measurement Information System:PROMIS questionnaire (min 8 max 40 points, lower score is better)
Measured: Baseline, Day 15, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non inferiority trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Heinzer, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845331
- Sponsor's protocol ID
- BioMAD
- Acronym
- BioMAD
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a New Mandibular Advancement Device (BioMAD) in the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07845331
- Acronym / sponsor ID
- BioMAD / BioMAD
- Conditions
- OSA - Obstructive Sleep Apnea
- Keywords
- osa, MAD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 28 Sep 2026 (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.
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea.
Detailed description
The severity of OSA and associated symptoms will be assessed with the patients' usual mandibular devive (MAD), with no treatment (after a wash-out period), and with the new treatment (BioMAD)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non inferiority trial
| Arm | Type | Receives |
|---|---|---|
| single arm | Active comparator | Device: BioMADThe patients will be recorded with their usual MAD Device, after a 2 week wash out period and under the new BioMAD device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (≥ 18 years) with diagnosis of obstructive sleep apnea (AHI ≥ 5/h).
- Current use of a ResMed or SomnoMed MAD for at least 3 months with reported adherence ≥ 4 hours/night.
- Ability and willingness to stop using the current MAD for a two-week wash-out period.
- Agrees to be informed on incidental findings
- Capable of giving informed consent.
Key exclusion criteria (6 listed)
- Predominant central sleep apnea.
- Known temporo-mandibular joint disorders or significant dental conditions that preclude MAD use.
- Recent dental surgery (< 1 month) or planned during the investigation.
- Known pregnancy, breastfeeding or planning pregnancy during the study;
- Professional drivers or occupations requiring constant vigilance (due to risk of increased sleepiness during wash-out).
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 |
|---|---|---|
| BioMADEvaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea | Device | single arm |
Primary outcome
Apnea Hypopnea Index
Time frame: Baseline, Day 15, Day 30
Number of apneas and hypopneas per hour of sleep measured by home polysomnography under the 3 study conditions: no treatment, standard MAD, and BioMAD.
4 secondary outcomes
The hypoxic burden
Time frame: Baseline, Day 15, Day 30
Sleep efficiency and EEG-based sleep microstructure metrics
Time frame: Baseline, Day 15, Day 30
Subjective daytime sleepiness
Time frame: Baseline, Day 15, Day 30
Patients reported outcome measures (PROMS)
Time frame: Baseline, Day 15, Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing BioMAD in people with OSA - Obstructive Sleep Apnea, run by University of Lausanne Hospitals.
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 5 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Broome, Prof (004121314 4199, martin.broome@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (time frame: Baseline, Day 15, Day 30). 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 28 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.