Objective titration using a deep learning facilitated wearable system versus conventional subjective titration in mandibular advancement device therapy for obstructive sleep apnea: A randomized controlled trial

Objective titration using a deep learning-facilitated wearable system versus conventional subjective titration in mandibular advancement device therapy for obstructive sleep apnea: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260703005

Enrollment

Registered

2026-07-03

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA) Sleep Apnea, Obstructive

Interventions

This procedure is guided by AHI data provided by a deep learning-based wearable system. Each patient will be individually instructed and trained to perform MAD titration at home. Patients will wear th

s self-reported symptoms and physical tolerance. Each patient will be individually instructed and trained to perform MAD titration at home. Patients will return to the hospital every two weeks. Depend

Experimental Device,Active Comparator Other

Belun-assisted titration,Subjective titration

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged equal to or more than 18 years, 2. Diagnosed with OSA by polysomnography according to adult OSA guidelines, 3. Referral for MAD therapy from a sleep physician, 4. No experience in using MAD therapy

Exclusion criteria

Exclusion criteria: 1. Insufficient number of teeth for MAD retention, 2. Poor periodontal status, defined as a Community Periodontal Index score equal to or more than 3, 3. Presence of temporomandibular symptoms based on the diagnostic criteria (DC/TMD 2014), 4. Craniofacial anomalies affecting the maxillofacial bones, e.g. cleft lip and palate, 5. Limited mandibular protrusion (< 6 mm), 6. Unwillingness to attend follow-up visits

Design outcomes

Primary

Measure	Time frame
The predicted effective target protrusive position At 2-3 months when a follow-up PSG is conducted. Millimetres	—

Secondary

Measure	Time frame
Efficacy of MAD therapy At 2-3 months when a follow-up PSG is conducted. The reduction in AHI based on PSG from baseline,Duration of the titration period At 2-3 months when a follow-up PSG is conducted. Time period,Improvement in subjective symptoms and snoring At 2-3 months when a follow-up PSG is conducted. Questionnaires, i.e. ESS, PSQI, and VAS for snoring score,Adherence to MAD therapy At 2-3 months when a follow-up PSG is conducted. Hour per night / self-reported questionnaires	—

Measure

Time frame

Efficacy of MAD therapy At 2-3 months when a follow-up PSG is conducted. The reduction in AHI based on PSG from baseline,Duration of the titration period At 2-3 months when a follow-up PSG is conducted. Time period,Improvement in subjective symptoms and snoring At 2-3 months when a follow-up PSG is conducted. Questionnaires, i.e. ESS, PSQI, and VAS for snoring score,Adherence to MAD therapy At 2-3 months when a follow-up PSG is conducted. Hour per night / self-reported questionnaires

—

Countries

Thailand

Contacts

Public ContactChidsanu Changsiripun

Faculty of Dentistry, Chulalongkorn University

Chidsanu.C@chula.ac.th0875130033

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026