Randomized Cross-over TRD and CPAP for OSA

NCT ID: NCT02788487

Last Updated: 2016-06-02

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-31

Brief Summary

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The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 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

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The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 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 1 week and Wash-out periods 1 week are required before start each treatment.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Tongue retaining device

Intervention Type DEVICE

Tongue retaining device is used for 3 weeks

CPAP

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Tongue retaining device

Intervention Type DEVICE

Tongue retaining device is used for 3 weeks

CPAP

Intervention Type DEVICE

CPAP is used for 3 weeks

Interventions

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Tongue retaining device

Tongue retaining device is used for 3 weeks

Intervention Type DEVICE

CPAP

CPAP is used for 3 weeks

Intervention Type DEVICE

Other Intervention Names

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Continuous positive airway pressure

Eligibility Criteria

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Inclusion Criteria

1. OSA patients aged over 18 years old at Siriraj hospital
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

1. Patients with severe periodontal diseases
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.
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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Anuch - Durongphan, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Wish - Banhiran, MD

Role: CONTACT

6699756405

Anuch - Durongphan, MD

Role: CONTACT

662 419 8040

Facility Contacts

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Wish - Banhiran, MD

Role: primary

6624198040

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.

Reference Type DERIVED
PMID: 31754961 (View on PubMed)

Other Identifiers

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R015932011

Identifier Type: -

Identifier Source: org_study_id

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