Compare Outcomes of SMG and CPAP in OSA

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Sleep Apnea Syndromes
• Intervention / Treatment: Device: CPAP; Device: Somnoguard

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
    • Contact: Wish Banhiran, MD; Phone Number: 6624198040; Email: wishbanh@hotmail.com
    • Principal Investigator: wish banhiran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP Therapy; Continuous Positive Airway Pressure	Device: CPAP; CPAP is used for 6 weeks; Other Names: Continuous positive airway pressure therapy
Experimental: Somnoguard	Device: Somnoguard; Somnoguard is used for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	FOSQ scores	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	questionnaires	6 weeks
satisfaction	VAS scores	6 weeks
AHI	Apnea-hypopnea index (events per hour)	6 weeks
Degree of sleepiness	ESS scores	6 weeks
lowest oxygen saturation	lowest oxygen saturation (%)	6 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Wish Banhiran, MD, Siriraj Hospital

Publications and helpful links

General Publications

• Banhiran W, Assanasen P, Nopmaneejumrudlers C, Nujchanart N, Srechareon W, Chongkolwatana C, Metheetrairut C. Adjustable thermoplastic oral appliance versus positive airway pressure for obstructive sleep apnea. Laryngoscope. 2018 Feb;128(2):516-522. doi: 10.1002/lary.26753. Epub 2017 Jul 17.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 9, 2016

Study Record Updates

• Last Update Posted (Estimate): May 9, 2016
• Last Update Submitted That Met QC Criteria: May 6, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: R015733017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No