The Use of Oral Appliances as an Adjunct to C-PAP in the Treatment of Obstructive Sleep Apnea
This study is currently recruiting patients
Verified by University of British Columbia July 2006
| Sponsored by: |
University of British Columbia |
| Information provided by: |
University of British Columbia |
| ClinicalTrials.gov Identifier: |
NCT00358605 |
Purpose
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 could use an oral appliance as an alternative would actually avail of its use, and to assess their preference in terms of treatment modality. The combination of therapies if tolerated, will allow greater flexibility of treatment and opportunity for ongoing compliance in circumstances where CPAP cannot be used.
| Condition |
Intervention |
| Obstructive Sleep Apnoea Hypopnoea Syndrome |
Device: The Klearway™ oral appliance |
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Study to Compare Oral Appliances to Standard CPAP Therapy in Patients With OSAHS, and to Assess Its Safety, Tolerability
and Efficacy and Preference Over CPAP for Its Short-Term Use.
Further study details as provided by University of British Columbia:
Primary Outcomes: This study will compare Apnea-hypopnea index (AHI) before and during oral appliance use.
Secondary Outcomes: This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between before and during oral
appliance therapy.; It will compare the change in Sleep Apnea Quality of Life Index while on CPAP from baseline to while on Oral appliance.; Overall treatment compliance; Overall sleepiness score (subjective)
Expected Total Enrollment:
30
Study start: August 2005;
Expected completion: August 2007
Last follow-up: February 2007;
Data entry closure: June 2007
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, occupation and change in symptoms. Weight, height
and neck circumference will be measured and BMI calculated and compared to previous measurements recorded in the medical chart.
The research question we are exploring is whether the oral appliance approach is better in terms of successful treatment,
compliance with treatment, safety and quality of life when compared to the conventional CPAP therapy in OSAHS. It is a cross
over design. Consecutive patients who
- meet the eligibility criteria
- agree to a trial of therapy with the oral appliance
- give informed consent will be recruited.
Inclusion criteria – stable on C-PAP for at least 3 months, and Previous diagnostic polysomnography within 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 Criteria - 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, Operates heavy machinery
or motor vehicle as part of job, or Clinical evidence of severe tempero-mandibular joint dysfunction, or Previous Motor Vehicle
Crash assoc. with sleepiness, or Major cardiovascular morbidity, or Medically complicated or medically unstable. Thirty patients
will be recruited over a period of 1 year. Prior to treatment baseline ESS and SAQLI will be recorded. Physical attributes
will be recorded and if BMI and neck circumference are unchanged from pre-treatment records PSG will be deemed unnecessary
at this point. Baseline RDI, and snoring index off treatment, will be recorded using portable snoresat monitoring.
All patients will visit the dental clinic for fitting and adjustment of the Klearway appliance. The appliance will be advanced
under supervision of the clinic and patients will be assessed at intervals of 2-4 weeks. Titration will be assessed clinically
based on patient sleepiness, snoring, comfort, and maximal jaw adjustment. Snoresat monitoring will be repeated while wearing
the appliance in the optimal position to ensure adequate titration. Once titration has been completed the patient will be
asked to wear the appliance exclusively for a period of at least 7 days. Full PSG will be recorded after 7 days while using
the appliance. ESS will be measured at the time of PSG. Treatment efficacy at this point will determine safety to continue
using the appliance. Treatment failure will be defined as an ESS >4 over baseline an AHI of >20 or > 50% of pre-treatment
baseline.
Patients will be seen and reassessed and informed of sleep study results. Patients able to use the appliance safely will be
asked to continue to use their OSA treatments individually and will be allowed to decide themselves which mode of therapy
they will use each night. Patients will keep a daily diary recording use of treatment modality, length of time worn and also
location (home, vacation etc). At the end of the study patients will be seen and diaries collected. Satisfaction levels will
assessed and side effects recorded. Objective CPAP compliance will be analysed by downloading CPAP machines. Future treatment
preference in terms of either treatment or a combination will be recorded.
Eligibility
Genders Eligible for Study:
Both
Criteria
Inclusion Criteria:
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 Criteria:
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.
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00358605
Canada, British ColumbiaUBC Sleep Disorder Program and Sleep Lab, UBC Hospital, Vancouver,
British Columbia,
Canada; Recruiting
Study chairs or principal investigators
John Fleetham, MD, Principal Investigator, The University of British Columbia
More Information
Study ID Numbers:
C05-0075
Last Updated:
July 28, 2006
Record first received:
July 28, 2006
ClinicalTrials.gov Identifier:
NCT00358605Health Authority: Canada: Health Canada ClinicalTrials.gov processed this record on 2006-10-18 |
