BioMAD - A Non-inferiority Study
ConditionOSA - Obstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Lausanne Hospitals
About this trial
Evaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
BioMAD
DeviceEvaluation of the effectiveness of a new mandibular advancement device (BioMAD) in the treatment of obstructive sleep apnea
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: single armActive comparator 1 intervention
Trial outcomes
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 30Secondary 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 302
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 303
Subjective daytime sleepiness
Measured using the Epworth sleepiness scale
Time frame
Baseline, Day 15, Day 304
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 30Other 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 302
Adverse effects related to BioMAD
Adverse effects evaluated by a specific ad hoc questionnaire
Time frame
At baseline (day 1) and at day 30Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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