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Preliminary clinical efficacy evaluation of a digital mandibular advancement device (MAD) for the treatment of obstructive sleep apnea hypoventilation syndrome (OSAHS)

To evaluate the clinical efficacy of a new digital mandibular advancement device (MAD) in the treatment of mild, moderate and severe cold sleep apnea hypopnea syndrome (OSAHS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107457
Enrollment
Unknown
Registered
2025-08-12
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Obstructive Sleep Apnea Hypoventilation Syndrome

Interventions

Control subjects:Conventional mandibular advancement appliance therapy
Observation Group 1:Digital mandibular advancement appliance therapy
Observation Group 2:Digital mandibular advancement orthodontic treatment with personalized lip stops

Sponsors

The Third Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-70 years with clear consciousness, good communication and positive PSG; (2) No previous OSAHS-related treatment; (3) Complete dentition and good joint condition.

Exclusion criteria

Exclusion criteria: (1) Sleep disorder diseases other than OSAHS, such as central sleep apnea, diagnosed after PSG examination; (2) Patients with a combination of serious heart and lung diseases, neuromuscular diseases, and psychosomatic diseases; (3) Patients who are receiving OSA treatments such as noninvasive positive pressure ventilation and oral braces; (4) Patients who refused to participate in this study.

Design outcomes

Primary

MeasureTime frame
AHI;Blood oxygen saturation;Epworth sleepiness;

Secondary

MeasureTime frame
Snoring scale;

Countries

China

Contacts

Public ContactWu Junjie

The Third Affiliated Hospital of Air Force Medical University

wujunjiedds@163.com+86 151 2906 2108

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026