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Comparison of the effects of two different mandibular advancement device on obstructive sleep apnea: a Randomized Controlled Trial

Comparison of the effects of two different mandibular advancement device on obstructive sleep apnea: a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092896
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Obstructive sleep apnea

Interventions

traditional mandibular advancement device
:traditional mandibular advancement device
invisible mandibular advancement device
:invisible mandibular advancement device

Sponsors

School of Stomatology, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were: 1. 30<=age<=65years old; 2. Ability to follow-up; 3. Patients were diagnosed as OSA by sleep monitoring at night. 4. Expected to maintain current lifestyle (e.g., sports, medicine, diet, etc.).

Exclusion criteria

Exclusion criteria: The exclusion criteria were: 1. Untreated periodontal problems, dental pain; 2. Medication usage that could influence respiration or sleep; 3. Evidence of respiratory/sleep disorders other than OSA ( e.g., central sleep apnea syndrome); 4. Systematic disorders (e.g., rheumatoid arthritis); 5. Severe temporomandibular disorders; 6. Coexistence of non-respiratory sleep disorders (e.g., insomnia, periodic limb movement disorder, or narcolepsy); 7. Known medical history of mental retardation, memory disorders,or psychiatric disorders; 8. Habit, such as smoking; 9. Previous treatment with CPAP; 10. The participants are relatives with each other.

Design outcomes

Primary

MeasureTime frame
AHI;

Secondary

MeasureTime frame
Minimum cross-sectional area of the upper airway;arousal threshold;muscle activity;

Countries

China

Contacts

Public ContactChen Hui

School of Stomatology, Shandong University

h.chen@sdu.edu.cn+86 155 6266 1031

Outcome results

None listed

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