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Status unknownNCT02788487Updated Jun 2, 2016

Randomized Cross-over TRD and CPAP for OSA

An interventional study of Tongue retaining device and CPAP in Obstructive Sleep Apnea, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-02.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

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Conditions studied

  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's planned enrollment of 36 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Mahidol University is the lead sponsor of 744 studies on the registry; 116 are open to participants now.

Browse Mahidol University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    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

    Device: Tongue retaining device · Device: CPAP

  • Experimental
    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

    Device: Tongue retaining device · Device: CPAP

Interventions

  • DeviceTongue retaining device

    Tongue retaining device is used for 3 weeks

  • DeviceCPAP

    CPAP is used for 3 weeks

    Also known as: Continuous positive airway pressure

06

What researchers measure

Primary outcomes

  1. apnea-hypopnea index (AHI)

    Time frame: 3 weeks

Secondary outcomes

  1. Functional outcomes of sleep questionnaire (FOSQ ) score

    Time frame: 3 weeks

  2. Epworth sleepiness score (ESS) scores

    Time frame: 3 weeks

  3. lowest oxygen saturation during sleep test at home

    Time frame: 3 weeks

  4. side effects questionnaire

    Time frame: 3 weeks

  5. satisfaction and preference of device questionnaire

    Time frame: 3 weeks

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Study locations

1 of 1 sites recruiting
  • Siriraj Hospital
    Bangkoknoi, Bangkok 10700, Thailand
    • Wish - Banhiran, MD · Contact · wishbanh@hotmail.com · 6624198040
    • wish - banhiran, MD · Principal investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 31754961 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Dec 2016 and a completion of May 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2016
First posted
Jun 2, 2016
Start
Jan 2016
Primary completionEst.
Dec 2016
CompletionEst.
May 2017
Last update
Jun 2, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02788487
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Jun 2, 2016
Start date
Jan 2016
Primary completion
Dec 2016 (estimated)
Completion
May 2017 (estimated)
Last update
Jun 2, 2016

Study contacts

Wish - Banhiran, MD
Contact
wishbanh@hotmail.com
6699756405
Anuch - Durongphan, MD
Contact
anuch.mai@gmail.com
662 419 8040
Anuch - Durongphan, MD
principal investigator · Siriraj Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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