NCT01466309

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

1.4 years

First QC Date

November 1, 2011

Last Update Submit

November 6, 2011

Conditions

OSAComplication

Keywords

AHIESSVASFOSQSF-36

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea index

    1 year

Secondary Outcomes (1)

  • Number of Participants with Adverse Events"

    1 year

Study Arms (1)

treatment

EXPERIMENTAL

patients treated with Somnoguard

Device: Somnoguard oral appliances

Interventions

Somnoguard oral appliancesDEVICE

wearing somnogaurd daily at bedtime

treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Study Officials

  • wish banhiran, MD

    Yes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 7, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 7, 2011

Record last verified: 2011-11

Locations

TH(1)