Treatment of Sleep Apnea With Oral Appliances

Obstructive Sleep Apnea Clinical Trial

Official title:

A Randomized Clinical Trial of the Treatment of Obstructive Sleep Apnoea Using Oral Appliances

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01209468
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2010
• Last updated: September 24, 2010
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: The University of Hong Kong
• Contact: Colman McGrath, Professor
• Phone: +852 28590513
• Email: mcgrathc[@]hkucc.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• monobloc oral appliance
one piece oral appliance
• twinblock oral appliance
two-piece oral appliance

Locations

Country	Name	City	State
Hong Kong	Prince Philip Dental Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life scores collected by the Sleep Apnoea Quality of Life Index questionnaire.; The minimum important clinical difference (MICD) for this index is a change in score of 1. A mean change of at least 1 in the SAQLI scores (SD=1.1) between the two groups (treated two types of oral appliances) is expected.	6 months	No
Secondary	objective OSA markers	Physiological variables measured during polysomnography, such as apnea-hypopnea index (AHI).; Complete response: Resolution of symptoms and improvement of objective variables Partial response: more than 50% reduction in AHI but AHI's remaining above 5/h Failure: ongoing clinincal symptoms and/or less than 50% reduction in AHI	6 months	No