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Compare Outcomes of SMG and CPAP in OSA

NCT02766179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-05-09

No results posted yet for this study

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.

Conditions

  • Quality of Life
  • Sleep Apnea Syndromes

Interventions

DEVICE

CPAP

CPAP is used for 6 weeks

DEVICE

Somnoguard

Somnoguard is used for 6 weeks

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Wish Banhiran, MD · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02766179 on ClinicalTrials.gov