Treatment of Sleep Apnea With Oral Appliances

NCT ID: NCT01209468

Last Updated: 2010-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-12-31

Brief Summary

Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five men and one in fifty women over the age of 30. This breathing abnormality occurs during sleep and is characterised by snoring and episodes of sleep disturbances. The symptoms of untreated OSA (e.g. excessive daytime sleepiness), can result in significant reductions in the patients' quality of life. The key treatment modalities today include Continuous Positive Air Pressure (CPAP), surgery and the use of oral appliances (OAs). Increasingly, OAs have been advocated in the treatment of the symptoms of OSA since they offer a non-invasive form of treatment and also because patients often prefer this treatment to other treatment modalities. There is increasing evidence to support the effectiveness of OAs in the management of OSA, at least as a short term measure. What is still unclear is which types of OA are most effective and whether OAs are effective in the long term management of OSA. This randomized clinical trial aims to evaluate two differently designed OAs in terms of their effect on patients' quality of life and on the physiological symptoms of OSA (apnoea/hypopnoea index AHI). Around 45 patients with OSA will be recruited from a pool of patients referred to the dental hospital for treatment from the medical faculty. The treatment with OAs will commence after randomization to two treatment groups; follow-up examinations will take place over a period of 12 months. The results of this study will help inform practitioners and patients of the feasibility of using OAs in the long term management of OSA and help determine the most appropriate type of OAs for the management of OSA and improvement in quality of life.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

oral appliance 2

Patients in treatment arm/group B will have a customized twinblock OA constructed for them individually. They will undergo an appliance acclimatization period of 4-5 weeks. Three months after baseline assessments - T1 (6 weeks of 'active' treatment), physiological measurements will be evaluated, clinical oral examinations conducted, quality of life and compliance assessed. Following this, a customized monobloc OA will be constructed for subjects individually and they will acclimatize to it for 4-5 weeks (so that the mandible is protruded to the maximum position they feel comfortable with when the appliance is worn). Prior to the active treatment phase, patients will not wear the monobloc OA for 1 week (washout phase). Three months later - T2 (6 weeks of 'active' treatment), all the previous measurements will be conducted again.

Group Type: ACTIVE_COMPARATOR

twinblock oral appliance

Intervention Type: DEVICE

two-piece oral appliance

oral appliance 1

Patients in treatment arm/group A will have a customized monobloc OA constructed for them individually. They will undergo an appliance acclimatization period of 4-5 weeks. Three months after baseline assessments - T1 (6 weeks of 'active' treatment), physiological measurements will be evaluated, clinical oral examinations conducted, quality of life and compliance assessed. Following this, a customized twin-bloc OA will be constructed for subjects individually and they will acclimatize to it for 4-5 weeks (so that the mandible is protruded to the maximum position they feel comfortable with when the appliance is worn). Prior to the active treatment phase, patients will not wear the twin-bloc OA for 1 week (washout phase). Three months later - T2 (6 weeks of 'active' treatment), all the previous measurements will be conducted again.

Group Type: EXPERIMENTAL

monobloc oral appliance

Intervention Type: DEVICE

one piece oral appliance

Interventions

monobloc oral appliance

one piece oral appliance

Intervention Type: DEVICE

twinblock oral appliance

two-piece oral appliance

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 18 or older
• AHI ≥ 10-30/h, and those who do not tolerate CPAP or refused CPAP if AHI >30
• A score of > 10 on the Epworth Sleepiness Scale
• Body Mass Index <35kg/m
• Those who are competent to give written informed consent
• have adequate dental anchoring structures (<10 periodontally healthy teeth per arch)

Exclusion Criteria

• Previous surgery to upper respiratory airway
• Concurrent unstable cardiovascular disease, neurological, mental or psychiatric disorders
• Recent major surgery in the last 6 months
• Pregnancy
• Epilepsy
• temporomandibular joint (TMJ) disfunction (pain during mandibular advancement or limitation of mouth opening)
• untreated dental decay

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Faculty of Dentistry, HKU

Principal Investigators

Colman McGrath, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, HKU

Locations

Prince Philip Dental Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Colman McGrath, Professor

Role: CONTACT

mcgrathc@hkucc.hku.hk

+852 28590513

Anika Ahrens, MA

Role: CONTACT

anikaahrens@yahoo.com

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id