Back to resultsCompare Outcomes of SMG and CPAP in OSA
Primary Purpose
Quality of Life, Sleep Apnea Syndromes
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
CPAP
Somnoguard
Sponsored by
About this trial
This is an interventional treatment trial for Quality of Life
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CPAP Therapy
Somnoguard
Arm Description
Continuous Positive Airway Pressure
Somnoguard
Outcomes
Primary Outcome Measures
Quality of life
FOSQ scores
Secondary Outcome Measures
side effects
questionnaires
satisfaction
VAS scores
AHI
Apnea-hypopnea index (events per hour)
Degree of sleepiness
ESS scores
lowest oxygen saturation
lowest oxygen saturation (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02766179
Brief Title
Compare Outcomes of SMG and CPAP in OSA
Official Title
A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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. Wash-in period 2 weeks and Wash-out periods 2 weeks are required before start each treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Sleep Apnea Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP Therapy
Arm Type
Active Comparator
Arm Description
Continuous Positive Airway Pressure
Arm Title
Somnoguard
Arm Type
Experimental
Arm Description
Somnoguard
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous positive airway pressure therapy
Intervention Description
CPAP is used for 6 weeks
Intervention Type
Device
Intervention Name(s)
Somnoguard
Intervention Description
Somnoguard is used for 6 weeks
Primary Outcome Measure Information:
Title
Quality of life
Description
FOSQ scores
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
side effects
Description
questionnaires
Time Frame
6 weeks
Title
satisfaction
Description
VAS scores
Time Frame
6 weeks
Title
AHI
Description
Apnea-hypopnea index (events per hour)
Time Frame
6 weeks
Title
Degree of sleepiness
Description
ESS scores
Time Frame
6 weeks
Title
lowest oxygen saturation
Description
lowest oxygen saturation (%)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wish Banhiran, MD
Phone
6699756405
Email
wishbanh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wish Banhiran, MD
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wish Banhiran, MD
Phone
6624198040
Email
wishbanh@hotmail.com
First Name & Middle Initial & Last Name & Degree
wish banhiran, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28714534
Citation
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.
Results Reference
derived
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Compare Outcomes of SMG and CPAP in OSA
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