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Trial registered on ANZCTR


Registration number
ACTRN12615000037505
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
19/01/2015
Date last updated
19/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label, Non-randomised study to evaluate the safety, efficacy, tolerability and compliance of the Tongue Tamer Mandibular Advancement Splint in patients with Obstructive Sleep Apnoea
Scientific title
An Open Label, Non-randomised study to evaluate the safety, efficacy, tolerability and compliance of the Tongue Tamer Mandibular Advancement Splint in patients with Obstructive Sleep Apnoea
Secondary ID [1] 285831 0
Nil
Universal Trial Number (UTN)
Trial acronym
TT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 293749 0
Condition category
Condition code
Respiratory 294048 294048 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the addition of the Tongue Tamer system to existing SomnoMed (Registered Trademark) Mandibular Advancement Splints (MAS) in patients not demonstrating a complete response with conventional MAS treatment. The Tongue Tamer is designed to hold the tongue in a more forward position, enhancing the ability of the appliance to keep the airways clear. Tongue Tamers will be inserted into existing devices by SomnoMed technicians and the participant will wear the device nightly for 4 weeks. During this time, daily compliance diaries will be kept to monitor adherence and a final sleep study with the modified device will be performed after 4 weeks. These sleep study results will be compared to each individual's sleep study with the conventional MAS prior to alteration.
Intervention code [1] 290810 0
Treatment: Devices
Comparator / control treatment
Active: Crossover study. Patients sleep study results will be compared before and after the Tongue Tamer alteration is inserted, after 4 weeks of use.
Control group
Active

Outcomes
Primary outcome [1] 293825 0
To determine the efficacy of the Tongue Tamer modification to reduce the overall Apnoea Hypopnea Index (AHI) when compared to the conventional MAS, as determined by a sleep study performed before (up to one year pre-modification) and after the modification.
Timepoint [1] 293825 0
After 4 weeks of using the Tongue Tamer modification
Primary outcome [2] 293882 0
To determine the safety of the Tongue Tamer modification, this will be monitored through the daily compliance diary.
Timepoint [2] 293882 0
After 4 weeks of using the Tongue Tamer modification
Secondary outcome [1] 311950 0
To determine the compliance of patients- number of patients that use the device for greater than 4 hours as recorded by their compliance diary.
Timepoint [1] 311950 0
After 4 weeks of using the Tongue Tamer modification
Secondary outcome [2] 311951 0
To determine the tolerability of the device- the number of patients who use the device overall, regardless of time used, as recorded by their daily compliance diary.
Timepoint [2] 311951 0
After 4 weeks of using the Tongue Tamer modification

Eligibility
Key inclusion criteria
1. Age greater than 18 years
2. Partial response to SomnoMed MAS, with residual moderate- severe OSA defined by polysomnograph (AHI greater than 15)
3. Tolerance and compliance (greater than 4 hours use per night) to MAS treatment
4. A clinical decision to undertake oral appliance treatment
5. Fluency in both written and spoken English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Central sleep apnoea
2. Need for immediate therapy (eg. Sleepy drivers)
3. Co-existing sleep disorder (eg. Narcolepsy, shift work)
4. Contraindications to oral appliance therapy (periodontal disease, dental caries, less than 10 teeth per dental arch, exaggerated gag reflex)
5. Regular use of sedatives, narcotics, or psychoactive drugs
6. Pregnant or breast feeding women
7. Inability to understand English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/01/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3258 0
Royal North Shore Hospital - St Leonards

Funding & Sponsors
Funding source category [1] 290404 0
Commercial sector/Industry
Name [1] 290404 0
SomnoMed
Country [1] 290404 0
Australia
Primary sponsor type
Individual
Name
Prof. Peter Cistulli
Address
Respiratory and Sleep Medicine
Level 8A
Royal North Shore Hospital
Pacific Highway
St Leonards
Sydney
2066
Country
Australia
Secondary sponsor category [1] 289122 0
None
Name [1] 289122 0
Address [1] 289122 0
Country [1] 289122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292096 0
North Sydney Local Health District
Ethics committee address [1] 292096 0
Research Office
Level 13
Kolling Building
Royal North Shore Hospital
Pacific Highway
St Leonards
Sydney
NSW
2065
Ethics committee country [1] 292096 0
Australia
Date submitted for ethics approval [1] 292096 0
Approval date [1] 292096 0
28/03/2014
Ethics approval number [1] 292096 0
HREC/13/HAWKE/414

Summary
Brief summary
Obstructive Sleep Apnoea is a common sleep-related breathing disorder and can be treated using a Mandibular Advancement Splint (MAS), an oral device worn during sleep which protrudes the mandible, improving airway calibre. Approximately two thirds of patients adequately resolve their sleep apnoea with this conventional therapy however; clinical trials have shown that the addition of a tongue restraining device significantly increases MAS effectiveness. This study will investigate the Tongue Tamer (TT) system, designed to be reversibly added to the conventional SomnoMed MAS to passively restrain the tongue. Safety, efficacy, tolerability and compliance of the TT MAS will be investigated in patients not demonstrating a complete response to conventional MAS treatment.
Trial website
Trial related presentations / publications
Public notes
Are you currently treated with a SomnoMed Mandibular Advancement Splint but still not demonstrating a complete resolution of your Sleep Apnoea?
Would you like to trial the Tongue Tamer Modification System designed to directly hold the tongue in a more forward position, in an effort to enhance the ability of the appliance to keep the airways clear?
Royal North Shore Hospital is currently trialling this new modification for the treatment of Sleep Apnoea. The trial consists of a fully reversible modification to your existing SomnoMed device and a monitored use over approximately 4 week.

Contacts
Principal investigator
Name 53474 0
Prof Peter Cistulli
Address 53474 0
Respiratory and Sleep Medicine
Level 8A
Royal North Shore Hospital
Pacific Highway
St Leonards
Sydney
NSW
2065
Country 53474 0
Australia
Phone 53474 0
+61 2 992 686 74
Fax 53474 0
+61 2 946 320 99
Email 53474 0
[email protected]
Contact person for public queries
Name 53475 0
Meghan Leigh
Address 53475 0
Respiratory and Sleep Medicine
Level 8A
Royal North Shore Hospital
Pacific Highway
St Leonards
Sydney
NSW
2065
Country 53475 0
Australia
Phone 53475 0
+61 2 946 329 25
Fax 53475 0
+61 2 946 320 99
Email 53475 0
[email protected]
Contact person for scientific queries
Name 53476 0
Meghan Leigh
Address 53476 0
Respiratory and Sleep Medicine
Level 8A
Royal North Shore Hospital
Pacific Highway
St Leonards
Sydney
NSW
2065
Country 53476 0
Australia
Phone 53476 0
+61 2 946 329 25
Fax 53476 0
+61 2 946 320 99
Email 53476 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

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