Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01466309

Acronym

ThaiSomnoguard

Enrollment

Registered

2011-11-07

Start date

2011-07-31

Completion date

2012-12-31

Last updated

2011-11-07

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

Conditions

Complication, OSA

Keywords

AHI, ESS, VAS, FOSQ, SF-36

Brief summary

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.

Detailed 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.

Interventions

DEVICESomnoguard oral appliances

wearing somnogaurd daily at bedtime

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Apnea-Hypopnea index	1 year

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events	1 year	Number of Participants with Adverse Events

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026