Study Results
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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UNKNOWN
NA
36 participants
INTERVENTIONAL
2016-01-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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CPAP1 use and TRD 2use
Wash-in period 1 week and Continuous positive airway pressure (CPAP) is used for 3 weeks then wash-out 1 week and Tongue retaining device (TRD) is used for another 3 weeks
Tongue retaining device
Tongue retaining device is used for 3 weeks
CPAP
CPAP is used for 3 weeks
TRD1 use and CPAP2 use
Wash-in period 1 week and Tongue retaining device (TRD) is used for 3 weeks then Wash-out period 1 week and Continuous positive airway pressure (CPAP) is used for another 3 weeks
Tongue retaining device
Tongue retaining device is used for 3 weeks
CPAP
CPAP is used for 3 weeks
Interventions
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Tongue retaining device
Tongue retaining device is used for 3 weeks
CPAP
CPAP is used for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI \> 30 events/h but lowest Oxygen saturation \> 70%
3. Positive consented form
Exclusion Criteria
2. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
3. total sleep time less than 2 hour during previous sleep study
4. Patients who could not tolerate the side effects of CPAP or TRD
5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Anuch - Durongphan, MD
Role: PRINCIPAL_INVESTIGATOR
Siriraj Hospital
Locations
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Siriraj Hospital
Bangkoknoi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Banhiran W, Durongphan A, Keskool P, Chongkolwatana C, Metheetrairut C. Randomized crossover study of tongue-retaining device and positive airway pressure for obstructive sleep apnea. Sleep Breath. 2020 Sep;24(3):1011-1018. doi: 10.1007/s11325-019-01942-z. Epub 2019 Nov 21.
Other Identifiers
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R015932011
Identifier Type: -
Identifier Source: org_study_id
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