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Establishment and Evaluation of 4D Virtual Imaging-Based Precision Positioning Technology for Oral Appliances and a Remote Intelligent Titration Management System

Establishment and Evaluation of 4D Virtual Imaging-Based Precision Positioning Technology for Oral Appliances and a Remote Intelligent Titration Management System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106373
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-07-30
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

OSAHS

Interventions

remote group:titrable oral appliance
conventional group:Conventional Oral Appliance for Obstructive Sleep Apnea

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) No gender restriction; baseline age = 18 years. (2) OSA severity classified as mild or moderate. (3) Complete demographic data, medical history, anthropometric measurements, and polysomnography (PSG) records. (4) Not enrolled in any other clinical trial within the past 3 months. (5) Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Prior diagnosis of severe OSA or any sleep-related breathing disorder other than OSA. (2) Presence of congenital disorders affecting the cardiovascular, respiratory, metabolic, neurological, digestive, or genitourinary systems. (3) Major psychiatric illnesses such as mania or schizophrenia. (4) Active infectious diseases, including but not limited to tuberculosis, HIV/AIDS, or syphilis. (5) Pregnancy. (6) Chronic use of corticosteroids or hormone replacement therapy. (7) Inability to comply with required examinations or investigations. (8) Concurrent participation in other drug or device clinical trials.

Design outcomes

Primary

MeasureTime frame
apnea hypopnea index, AHI;

Secondary

MeasureTime frame
Consultation time;blood pressure;Pittsburgh sleep quality index, PSQI;

Countries

China

Contacts

Public ContactGao Xuemei

Peking University School and Hospital of Stomatology

xmgao@263.net+86 10 8219 5350

Outcome results

None listed

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