Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000533291
Ethics application status
Approved
Date submitted
29/06/2009
Date registered
2/07/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the role of unattended sleep monitoring in the management of patients with sleep apnoea being treated with an oral appliance.
Scientific title
Evaluation of a Portable Sleep Monitoring Device (ApneaLink) to Improve Outcomes of Oral Appliance Therapy in the Management of Patients with Obstructive Sleep Apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 237115 0
Condition category
Condition code
Respiratory 237443 237443 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ApneaLink monitor will be used in the intervention group to measure baseline sleep apnoea severity and then again to measure the response to treatment. It is an overnight simplified sleep monitoring device. It will be used when the dentist feels that the oral appliance has been optimally titrated and then again if any further advancement is done. If the ApneaLink shows that the sleep apnoea is still inadequately treated, further advancement will be attempted and another ApneaLink study done. Thus the ApneaLink device will be used at least twice and it may be used several more times, depending on the adequacy of treatment and requirement for further advancement of the mandible with the oral appliance.
Intervention code [1] 236838 0
Treatment: Devices
Comparator / control treatment
Usual care. This involves an initial visit to the dentist to assess suitability for treatment with an oral appliance. A mould of the teeth is then taken and sent away for manufacture of the oral appliance. At the next visit, the oral appliance is fitted and advanced to the limits of patient comfort. Subsequently, patients are seen fortnightly with further advancement of the mandible as possible. Usually the patient visits the dentist 4 or 5 times before advancement is considered complete. At this time, an in-laboratory diagnostic sleep study will be done to assess treatment efficacy.
Control group
Active

Outcomes
Primary outcome [1] 238245 0
The Apnoea Hypopnoea Index will be the primary outcome. This outcome will be measured by a full in-laboratory overnight polysomnogram.
Timepoint [1] 238245 0
For participants in the control arm this endpoint will be measured 1 month after participants are comfortable with using the oral appliance on a nightly basis. For participants in the intervention arm, it will be measured 1 month after advancement is considered to be optimal.
Secondary outcome [1] 244582 0
Quality of Life - measured by Functional Outcomes of sleep questionnaire and the sf36 questionnaire
Symptoms - measured by the Sleep Apnoea Symptom Questionnaire
Subjective Sleepiness - measured by the Epworth Sleepiness Scale
Timepoint [1] 244582 0
For participants in the control arm this endpoint will be measured 1 month after participants are comfortable with using the oral appliance on a nightly basis. For participants in the intervention arm, it will be measured 1 month after advancement is considered to be optimal.

Eligibility
Key inclusion criteria
Mild to moderate obstructive sleep apnoea (OSA) referred for oral appliance treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor oral hygiene
Inadequate dentition
Unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients referred to one of the 2 participating dentists will be considered for inclusion. If they meet inclusion/exclusion criteria and sign informed consent, they will be randomly allocated to usual care or usual care plus portable sleep monitor. Randomisation will be done centrally, with an administrative research assistant allocating participants to a treatment arm. This will done by faxing participant details to the central site. Subjects will be stratified according to the severity of their sleep apnoea, with an apnoea hypopnoea index cutpoint of 25. The research assistant will then allocate the subject the next number on the list of random numbers that has been generated. Subjects with odd numbers will be allocated to the intervention arm, those with even numbers will be allocated to the control arm.
The research assistant is not involved in recruiting, consenting or treating participants. She will fax the treatment allocation back to the treating dentist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1861 0
3084

Funding & Sponsors
Funding source category [1] 237227 0
Self funded/Unfunded
Name [1] 237227 0
Maree Barnes
Country [1] 237227 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep
Address
Austin Health
PO Box 5555
Heidelberg 3084
Country
Australia
Secondary sponsor category [1] 236718 0
None
Name [1] 236718 0
Address [1] 236718 0
Country [1] 236718 0
Other collaborator category [1] 734 0
Individual
Name [1] 734 0
Christopher Lloyd
Address [1] 734 0
114 Clarke St
South Bunbury WA 6230
Country [1] 734 0
Australia
Other collaborator category [2] 735 0
Individual
Name [2] 735 0
Andrew Gikas
Address [2] 735 0
1550 Dandenong Rd
Oakleigh VIC 3166
Country [2] 735 0
Australia
Other collaborator category [3] 736 0
Individual
Name [3] 736 0
Christiane deChaneet
Address [3] 736 0
St John Of God Medical Centre
Bussell Hwy (cnr Robertson Drive)
Bunbury WA 6230
Country [3] 736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239328 0
Austin Health
Ethics committee address [1] 239328 0
Ethics committee country [1] 239328 0
Australia
Date submitted for ethics approval [1] 239328 0
Approval date [1] 239328 0
25/06/2009
Ethics approval number [1] 239328 0
H2009/03569

Summary
Brief summary
All patients attending 2 dental practices for oral appliance therapy to treat obstructive sleep apnoea will be assessed for recruitment. Those who are able to sign informed consent will be enrolled. If a polysomnogram (PSG) has not been done, this will be done to confirm the apnoea hypopnoea index (AHI). Participants will be randomised to either usual care or usual care plus an apnealink study to evaluate treatment response. Should treatment response be inadequate as indicated by the ApneaLink in this group, further advancement of the mandible will be attempted. A repeat ApneaLink study will then be done and the process repeated. One month after titration is considered optimal, repeat PSG will be done. A repeat PSG will be done 1 month after optimal titration has been achieved in the control group. Secondary outcome measures of quality of life, symptoms and subjective sleepiness will be measured at baseline and at the time of the repeat PSG in both groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29813 0
Address 29813 0
Country 29813 0
Phone 29813 0
Fax 29813 0
Email 29813 0
Contact person for public queries
Name 13060 0
Maree Barnes
Address 13060 0
Institute for Breathing and Sleep
PO Box 5555 Heidleberg
Victoria 3084
Country 13060 0
Australia
Phone 13060 0
613 9496 3874
Fax 13060 0
Email 13060 0
[email protected]
Contact person for scientific queries
Name 3988 0
Maree Barnes
Address 3988 0
Institute for Breathing and Sleep
PO Box 5555 Heidleberg
Victoria 3084
Country 3988 0
Australia
Phone 3988 0
613 9496 3874
Fax 3988 0
Email 3988 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.