Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA (ThaiSomnoguard)

Mahidol University

Status: Unknown

Conditions: Complication; OSA

Treatments: Device: Somnoguard oral appliances

Study type: Interventional

Funder types: Other

Identifiers

NCT01466309

Somnoguard in Thai OSA

Details and patient eligibility

About

Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.

Full description

Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years with OSA
• AHI > 5
• Refused CPAP therapy

Exclusion criteria

• Poor oral hygiene
• Untreated TMD
• Inadequate healthy teeth (< 6)
• Severe or unstable medical problems.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

treatment

Experimental group

Description:

patients treated with Somnoguard

Treatment:

Device: Somnoguard oral appliances