BioMAD - A Non-inferiority Study

NCT07845331 | Not Yet Recruiting

• 1 other identifier: BioMAD
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

OSA - Obstructive Sleep Apnea

Keywords

osa; MAD

Outcome Measures

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.

  Baseline, Day 15, Day 30

Secondary Outcomes (4)

• The hypoxic burden

  Baseline, Day 15, Day 30

• Sleep efficiency and EEG-based sleep microstructure metrics

  Baseline, Day 15, Day 30

• Subjective daytime sleepiness

  Baseline, Day 15, Day 30

• Patients reported outcome measures (PROMS)

  Baseline, Day 15, Day 30

Other Outcomes (2)

• Patients comfort under treatment

  Baseline, day 30

• Adverse effects related to BioMAD

  At baseline (day 1) and at day 30

Study Arms (1)

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

Device: BioMAD

Interventions

BioMAD DEVICE

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

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Martin Broome, Prof

CONTACT

004121314 4199; martin.broome@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Non inferiority trial

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09