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A novel single-center study of non-customized titratable orthodontic therapy for mild to moderate obstructive sleep apnea (OSA)

A novel single-center study of non-customized titratable orthodontic therapy for mild to moderate obstructive sleep apnea (OSA)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079465
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-25
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

mild to moderate obstructive sleep apnea (OSA)

Interventions

Mild to moderate OSAHS patients with oral appliances:Wearing oral appliances

Sponsors

Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18~60 years old 2. Slightly to moderately obstructive OSA 3. Obstruction in palatopharynx and glossopharynx, Friedman II-III type. 4. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Age 60 years old; 2. Turbinate hypertrophy, deviated nasal septum, inflammation and other causes of airway obstruction; 3. Severe temporomandibular joint disorder; 4. History of craniomaxillofacial trauma and surgery; 5. Anterior teeth against the edge; 6. Less than 10 evenly distributed healthy abutments or severe periodontal disease, severe loose teeth; 7. BMI = 30 kg/m2 ; 8. Unable to take care of themselves, suffering from mental illness and psychological illness. According to the medical history except respiratory, circulatory, endocrine, urinary system and other diseases, such as asthma, hypothyroidism, acromegaly, prostate hypertrophy; 9. Patients with long-term use of drugs that affect sleep, such as benzodiazepines, sedative drugs.

Design outcomes

Primary

MeasureTime frame
AHI;Comfort value;

Secondary

MeasureTime frame
Equipment performance evaluation;Drowsiness;sleep status;

Countries

China

Contacts

Public ContactXia Gao

Department of Otolaryngology Head and Neck Surgery, Affiliated Drum Tower Hospital of Nanjing University Medical School

gaoxiadth@outlook.com+86 139 5182 9819

Outcome results

None listed

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