Status:
COMPLETED
The Use of Oral Appliances as an Adjunct to Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnoea
Lead Sponsor:
University of British Columbia
Conditions:
Obstructive Sleep Apnoea
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study will look at whether patients with OSAHS already successfully treated with nasal CPAP could successfully use an oral appliance as a short-term treatment alternative and whether patients who...
Detailed Description
Each patient will undergo a detailed history and physical examination with particular attention to symptoms related to sleep disorders, cardiovascular disease, medications, motor vehicle accidents, oc...
Eligibility Criteria
Inclusion
- stable on C-PAP for at least 3 months, and
- Previous diagnostic polysomnography ithin 2 years, and
- Pre-treatment AHI 10-30 ( mild-moderate sleep apnea), and
- Compliance \> 4hrs per night, and
- are willing and able to give informed consent
Exclusion
- AHI \>30, or
- Oxygen Saturation \< 85% for \> 10% of study time during previous diagnostic PSG;
- Or less than 8 teeth per jaw;
- Or not enough teeth in good periodontal health to allow retention of the appliance;
- Clinical evidence of severe tempero-mandibular joint dysfunction;
- Operates heavy machinery or motor vehicle as part of job;
- previous Motor Vehicle Crash assoc. with sleepiness;
- or major cardiovascular morbidity;
- or medically complicated or medically unstable.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00358605
Start Date
August 1 2005
End Date
December 1 2011
Last Update
May 20 2016
Active Locations (1)
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1
Vancouver Acute Sleep Disorder Program, UBC Hospital
Vancouver, British Columbia, Canada