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Not yet recruitingNCT07845331BioMADUpdated Sep 28, 2026

BioMAD - A Non-inferiority Study

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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)

02

Conditions studied

  • OSA - Obstructive Sleep Apnea

Keywords

  • osa
  • MAD
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult (≥ 18 years) with diagnosis of obstructive sleep apnea (AHI ≥ 5/h).
  2. Current use of a ResMed or SomnoMed MAD for at least 3 months with reported adherence ≥ 4 hours/night.
  3. Ability and willingness to stop using the current MAD for a two-week wash-out period.
  4. Agrees to be informed on incidental findings
  5. Capable of giving informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Predominant central sleep apnea.
  2. Known temporo-mandibular joint disorders or significant dental conditions that preclude MAD use.
  3. Recent dental surgery (\< 1 month) or planned during the investigation.
  4. Known pregnancy, breastfeeding or planning pregnancy during the study;
  5. Professional drivers or occupations requiring constant vigilance (due to risk of increased sleepiness during wash-out).
  6. Participation in another interventional trial or use of medications affecting sleep (sedative/hypnotic agents, opioids, muscle relaxants).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    single arm

    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

Interventions

  • DeviceBioMAD

    Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Subjective daytime sleepiness

    Measured using the Epworth sleepiness scale

    Time frame: Baseline, Day 15, Day 30

  4. 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

Other outcomes

  1. 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

  2. Adverse effects related to BioMAD

    Adverse effects evaluated by a specific ad hoc questionnaire

    Time frame: At baseline (day 1) and at day 30

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845331
Lead sponsor
University of Lausanne Hospitals
Responsible party
Raphael Heinzer (Associate Professor, University of Lausanne Hospitals) — Principal investigator
First posted
Sep 28, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Martin Broome, Prof
Contact
martin.broome@chuv.ch
004121314 4199

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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