Treatment of Sleep Apnea With Oral Appliances

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01209468
First received: September 24, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: monobloc oral appliance
Device: twinblock oral appliance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of the Treatment of Obstructive Sleep Apnoea Using Oral Appliances

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • objective OSA markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 45
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: twinblock oral appliance
two-piece oral appliance
Experimental: 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.
Device: monobloc oral appliance
one piece oral appliance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209468

Contacts
Contact: Colman McGrath, Professor +852 28590513 mcgrathc@hkucc.hku.hk
Contact: Anika Ahrens, MA anikaahrens@yahoo.com

Locations
Hong Kong
Prince Philip Dental Hospital Recruiting
Hong Kong, Hong Kong
Principal Investigator: Colman McGrath, Professor         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Colman McGrath, Professor Faculty of Dentistry, HKU
  More Information

No publications provided

Responsible Party: Professor Colman McGrath, Faculty of Dentistry, HKU
ClinicalTrials.gov Identifier: NCT01209468     History of Changes
Other Study ID Numbers: 1
Study First Received: September 24, 2010
Last Updated: September 24, 2010
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014