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Clinical Effect of personalized adjustable oral appliance on obstructive sleep apnea

Clinical Effect of personalized adjustable oral appliance on obstructive sleep apnea

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080306
Enrollment
Unknown
Registered
2024-01-25
Start date
2023-11-10
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

the obstructive sleep apnea syndrome

Interventions

experimental group:personalized adjustable oral appliance
control group:traditional oral appliance

Sponsors

The Stomatology department of the Air Force Hospital from Northern Theater of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diagnosed as mild to moderate OSA patients by nighttime polysomnography at our hospital, aged 30-70 years old; There should be no less than 10 teeth in a single jaw, no posterior teeth missing, and periodontal looseness should not exceed II degrees; There are no obvious discomfort symptoms or organic changes in the temporomandibular joint.

Exclusion criteria

Exclusion criteria: Space occupying lesions in the throat and nose due to obstruction of the expiratory tract; Women's history of taking sex hormones; Perform craniopharyngeal surgery or take medication such as bronchodilation and respiratory center stimulation while wearing oral appliances.

Design outcomes

Primary

MeasureTime frame
apnea index;

Secondary

MeasureTime frame
the area of upper airway cross-section;temporomandibular joint morphology;temporomandibular joint motion trajectories;sleep structure staging;mean blood oxygen saturation;lowest blood oxygen saturation;

Countries

China

Contacts

Public ContactWang Wei

The Stomatology department of the Air Force Hospital from Northern Theater of PLA

wangwei19831120@126.com+86 186 2406 7780

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026