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Trial registered on ANZCTR


Registration number
ACTRN12618000207213
Ethics application status
Approved
Date submitted
9/01/2018
Date registered
9/02/2018
Date last updated
9/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mouthguard and positional trainer( vibrating collar) in supine sleep apnoea..
Scientific title
Mandibular advancement splint and positional therapy for the treatment of moderate to severe positional obstructive sleep apnoea: a pilot randomised controlled study (MASPOT)
Secondary ID [1] 293744 0
None
Universal Trial Number (UTN)
U1111-1207-4020
Trial acronym
MASPOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ostructive sleep apnoea 306121 0
Positional obstructive sleep apnoea 306122 0
supine predominant sleep apnoea 306124 0
positional sleep apnoea 306125 0
Condition category
Condition code
Respiratory 305240 305240 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 MAS only. (a custom fitted trial mandibular advancement splint). This intervention involves a custom built mouth guard built by an orthodontist for the needs of the patient. this will be initally fitted and will have a 2 week period of trial phase and acclimatisation phase. Patients are requested to wear as many hours as possible as tolerated during sleep.
During the active phase of treatment, the patients are advised to wear it for the duration of sleep. The usage will be monitored by a chip inserted in the mouthguard..


Arm 2 MAS + POT. (Nightshift sleep positioned, Advanced Brain Monitoring, Inc Carlsbad, CA USA), This will involve the mouth guard as in Arm 1 and inaddition the patients will be given a vibrating collar called a night shift, which will vibrate on supine position. This will be worn in arm 2 of the study. The vibrator is to be worn as long as possible during the night. again the data of usage for 5 nights could be measured via the software of the device. It has capacity to monitor only approximately 5 hrs, hence to monitor for 5 days.
Cross over study with a wash out period of 2 weeks.
Intervention code [1] 299998 0
Treatment: Devices
Comparator / control treatment
There will be only 2 arms to the study. There is will no arm with no treatment. The 2 arms will cross over, hence will be their own controls.
Control group
Active

Outcomes
Primary outcome [1] 304395 0
Polysomnography – Residual apnoea- hypopnea index(AHI)
Timepoint [1] 304395 0
after one month of treatment.
Primary outcome [2] 304460 0
Residual Oxygen desaturation index(ODI) on each treatment arm)
Timepoint [2] 304460 0
after one month of treatment.
Secondary outcome [1] 341812 0
Objective MAS compliance measurements. There will be thermo chip implanted in the MAS which will record the hours of usage of the device. The average usage of the MAS over a period of 1 month will be analysed.
Timepoint [1] 341812 0
After one month
Secondary outcome [2] 341813 0
Change in Epworth sleepiness score (ESS) from baseline.
Timepoint [2] 341813 0
after one month

Eligibility
Key inclusion criteria
1. Males & Females ages 18 – 60 years
2. Moderate to Severe OSA (Apnoea-Hypopnea Index (AHI) > 15/hr) and
3. Supine dependent OSA (Supine to non-supine AHI ratio > 4)
4. CPAP intolerant/refusal
5. Minimum of ten teeth per dental arch
6. Sufficient dental health (No periodontitis)
7. Free from temporo mandibular joint pain
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. BMI > 35 kg/m2
3. Unstable Angina/ Heart Failure (NYHA Class III or IV)/ Stroke
4. Recent (<6months) AMI or Revascularization Procedure.
5. Significant Arrhythmia or Atrial Fibrillation.
6. Recent (<3 months) exposure to OSA therapy with MAS.
7. Severe OSA who are excessively sleepy ( ESS> 16)with increased risk for driving-related accidents.
8. Regular use of sedatives, narcotics, or psychoactive drugs.
9. Contraindications to oral appliance therapy (periodontal disease or dental caries, less than 10 teeth per dental arch, and exaggerated gag reflex).

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2018
Actual
Date of last participant enrolment
Anticipated
15/03/2019
Actual
Date of last data collection
Anticipated
15/05/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9784 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 18562 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 298356 0
Hospital
Name [1] 298356 0
John Hunter hospital charitable trust grant
Country [1] 298356 0
Australia
Primary sponsor type
Individual
Name
Shyamala Pradeepan
Address
New castle sleep disders service, John Hunter Hospital, Look out road,New lambton, NSW 2305
Country
Australia
Secondary sponsor category [1] 297538 0
Individual
Name [1] 297538 0
Joachim Ngiam
Address [1] 297538 0
50, Smith Street, Charlestown NSW 2290.
Country [1] 297538 0
Australia
Secondary sponsor category [2] 297539 0
Hospital
Name [2] 297539 0
John Hunter Hospital, Newcastle sleep diosders service.
Address [2] 297539 0
Look Out Road, New lambton, NSW 2305.
Country [2] 297539 0
Australia
Secondary sponsor category [3] 297540 0
University
Name [3] 297540 0
University of Newcastle
Address [3] 297540 0
University Drive, Callaghan, NSW 2308
Country [3] 297540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299351 0
Hunter New England Ethics committee
Ethics committee address [1] 299351 0
Ethics committee country [1] 299351 0
Australia
Date submitted for ethics approval [1] 299351 0
Approval date [1] 299351 0
12/10/2017
Ethics approval number [1] 299351 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2319 2319 0 0
/AnzctrAttachments/374273-MASPOT study Ngiam v1 mas study.docx (Protocol)

Contacts
Principal investigator
Name 80150 0
Dr Shyamala Pradeepan
Address 80150 0
Newcastle sleep disorders service,
John Hunter Hospital.
Look Out road,
New lambton, NSW 2305
Country 80150 0
Australia
Phone 80150 0
+61249223150
Fax 80150 0
+61249223160
Email 80150 0
[email protected]
Contact person for public queries
Name 80151 0
Shyamala Pradeepan
Address 80151 0
Newcastle sleep disorders service,
John Hunter Hospital.
Look Out Road,
New lambton, NSW 2305
Country 80151 0
Australia
Phone 80151 0
+61249223150
Fax 80151 0
+61249223160
Email 80151 0
[email protected]
Contact person for scientific queries
Name 80152 0
Shyamala Pradeepan
Address 80152 0
Newcastle sleep disorders service,
John Hunter Hospital.
Look out road,
New lambton, NSW 2305
Country 80152 0
Australia
Phone 80152 0
+61249223150
Fax 80152 0
+61249223160
Email 80152 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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