Randomized Cross-over TRD and CPAP for OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

A Randomized Cross-over Study of Tongue Retaining Device and Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02788487
• Other study ID #: R015932011
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2016
• Last updated: June 1, 2016
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: Wish - Banhiran, MD
• Phone: 6699756405
• Email: wishbanh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Tongue retaining device
Tongue retaining device is used for 3 weeks
• CPAP
CPAP is used for 3 weeks

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea-hypopnea index (AHI)		3 weeks
Secondary	Functional outcomes of sleep questionnaire (FOSQ ) score		3 weeks
Secondary	Epworth sleepiness score (ESS) scores		3 weeks
Secondary	lowest oxygen saturation during sleep test at home		3 weeks
Secondary	side effects questionnaire		3 weeks
Secondary	satisfaction and preference of device questionnaire		3 weeks