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Compare Outcomes of SMG and CPAP in OSA

M

Mahidol University

Status

Unknown

Conditions

Sleep Apnea Syndromes
Quality of Life

Treatments

Device: CPAP
Device: Somnoguard

Study type

Interventional

Funder types

Other

Identifiers

NCT02766179
R015733017

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 2 patient groups

CPAP Therapy
Active Comparator group
Description:
Continuous Positive Airway Pressure
Treatment:
Device: CPAP
Somnoguard
Experimental group
Description:
Somnoguard
Treatment:
Device: Somnoguard

Trial contacts and locations

1

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Central trial contact

Wish Banhiran, MD

Data sourced from clinicaltrials.gov

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