Compare Outcomes of SMG and CPAP in OSA

Quality of Life Clinical Trial

Official title:

A Randomized Cross-over Study of Adjustable Thermoplastic Oral Appliances and Continuous Positive Airway Pressure in Treatment of Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02766179
• Other study ID #: R015733017
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2016
• Last updated: May 6, 2016
• Start date: October 2014
• Est. completion date: December 2016

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 Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 Adjustable thermoplastic oral appliance in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 6-week period of each treatment in 50 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 2 weeks and Wash-out periods 2 weeks are required before start each treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• 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 YO at Siriraj hospital

2. AHI 5 - 30 events/ h or AHI > 30 events/h but lowest O2 saturation > 70%

3. Positive consented form

Exclusion Criteria:

1. Patients with severe Temporomandibular joint diseases or limited mandible advancement (< 5 mm)

2. Patients with severe periodontal diseases or inadequate teeth (< 3 teeth in each quadrant)

3. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, COPD, cancers, cerebrovascular diseases, epilepsy, dementia, etc.

4. Patients who could not tolerate the side effects of CPAP or SMG

5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.

Related Conditions & MeSH terms

• Quality of Life
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP
CPAP is used for 6 weeks
• Somnoguard
Somnoguard is used for 6 weeks

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	FOSQ scores	6 weeks
Secondary	side effects	questionnaires	6 weeks
Secondary	satisfaction	VAS scores	6 weeks
Secondary	AHI	Apnea-hypopnea index (events per hour)	6 weeks
Secondary	Degree of sleepiness	ESS scores	6 weeks
Secondary	lowest oxygen saturation	lowest oxygen saturation (%)	6 weeks