Randomized Cross-over TRD and CPAP for OSA

Mahidol University

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP; Device: Tongue retaining device

Study type: Interventional

Funder types: Other

Identifiers

NCT02788487

R015932011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

CPAP1 use and TRD 2use

Active Comparator group

Description:

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

Treatment:

Device: Tongue retaining device

Device: CPAP

TRD1 use and CPAP2 use

Experimental group

Description:

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

Treatment:

Device: Tongue retaining device

Device: CPAP