NCT02788487

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

May 27, 2016

Last Update Submit

June 1, 2016

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • apnea-hypopnea index (AHI)

    3 weeks

Secondary Outcomes (5)

  • Functional outcomes of sleep questionnaire (FOSQ ) score

    3 weeks

  • Epworth sleepiness score (ESS) scores

    3 weeks

  • lowest oxygen saturation during sleep test at home

    3 weeks

  • side effects questionnaire

    3 weeks

  • satisfaction and preference of device questionnaire

    3 weeks

Study Arms (2)

CPAP1 use and TRD 2use

ACTIVE COMPARATOR

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 deviceDevice: CPAP

TRD1 use and CPAP2 use

EXPERIMENTAL

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 deviceDevice: CPAP

Interventions

Tongue retaining deviceDEVICE

Tongue retaining device is used for 3 weeks

CPAP1 use and TRD 2useTRD1 use and CPAP2 use
CPAPDEVICE

CPAP is used for 3 weeks

Also known as: Continuous positive airway pressure
CPAP1 use and TRD 2useTRD1 use and CPAP2 use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSA patients aged over 18 years old at Siriraj hospital
  • Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI \> 30 events/h but lowest Oxygen saturation \> 70%
  • Positive consented form

You may not qualify if:

  • Patients with severe periodontal diseases
  • Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
  • total sleep time less than 2 hour during previous sleep study
  • Patients who could not tolerate the side effects of CPAP or TRD
  • Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31754961DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Anuch - Durongphan, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wish - Banhiran, MD

CONTACT

6699756405wishbanh@hotmail.com

Anuch - Durongphan, MD

CONTACT

662 419 8040anuch.mai@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 2, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

June 2, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)