An interventional study of BioMAD in OSA - Obstructive Sleep Apnea, sponsored by University of Lausanne Hospitals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Treatment
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Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea.
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)
2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Lausanne Hospitals is the lead sponsor of 120 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients will be recorded with their usual MAD Device, after a 2 week wash out period and under the new BioMAD device
Device: BioMAD
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea
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.
Time frame: Baseline, Day 15, Day 30
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
Time frame: 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
Time frame: Baseline, Day 15, Day 30
Subjective daytime sleepiness
Measured using the Epworth sleepiness scale
Time frame: 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)
Time frame: Baseline, Day 15, Day 30
Patients comfort under treatment
Specific tolerance and comfort questionnaire Will be compared between the standard MAD treatment and the BioMAD treatment: qualitative assessment (no score)
Time frame: Baseline, day 30
Adverse effects related to BioMAD
Adverse effects evaluated by a specific ad hoc questionnaire
Time frame: At baseline (day 1) and at day 30
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 7 months is below that.
Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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