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Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA

NCT ID: NCT01466309

Last Updated: 2011-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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OSA Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

patients treated with Somnoguard

Group Type EXPERIMENTAL

Somnoguard oral appliances

Intervention Type DEVICE

wearing somnogaurd daily at bedtime

Interventions

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Somnoguard oral appliances

wearing somnogaurd daily at bedtime

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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wish banhiran, MD

Role: PRINCIPAL_INVESTIGATOR

Yes

Locations

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Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Somnoguard in Thai OSA

Identifier Type: -

Identifier Source: org_study_id