Compare Outcomes of SMG and CPAP in OSA
A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea
1 other identifier
interventional
50
1 country
1
Brief Summary
The objectives of this study is to compare short-term outcomes of CPAP and Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Oct 2014
Typical duration for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 9, 2016
May 1, 2016
2.2 years
May 4, 2016
May 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life
FOSQ scores
6 weeks
Secondary Outcomes (5)
side effects
6 weeks
satisfaction
6 weeks
AHI
6 weeks
Degree of sleepiness
6 weeks
lowest oxygen saturation
6 weeks
Study Arms (2)
CPAP Therapy
ACTIVE COMPARATORContinuous Positive Airway Pressure
Somnoguard
EXPERIMENTALSomnoguard
Interventions
CPAP is used for 6 weeks
Eligibility Criteria
You may qualify if:
- OSA patients aged over 18 YO at Siriraj hospital
- AHI 5 - 30 events/ h or AHI \> 30 events/h but lowest O2 saturation \> 70%
- Positive consented form
You may not qualify if:
- Patients with severe Temporomandibular joint diseases or limited mandible advancement (\< 5 mm)
- Patients with severe periodontal diseases or inadequate teeth (\< 3 teeth in each quadrant)
- Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
- Patients who could not tolerate the side effects of CPAP or SMG
- Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
Banhiran W, Assanasen P, Nopmaneejumrudlers C, Nujchanart N, Srechareon W, Chongkolwatana C, Metheetrairut C. Adjustable thermoplastic oral appliance versus positive airway pressure for obstructive sleep apnea. Laryngoscope. 2018 Feb;128(2):516-522. doi: 10.1002/lary.26753. Epub 2017 Jul 17.
PMID: 28714534DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wish Banhiran, MD
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 9, 2016
Study Start
October 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 9, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share