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Trial registered on ANZCTR


Registration number
ACTRN12621000308897
Ethics application status
Approved
Date submitted
29/01/2021
Date registered
19/03/2021
Date last updated
30/06/2024
Date data sharing statement initially provided
19/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and tolerability of a novel adjustable mandibular advancement device (iSlpr®) for Obstructive Sleep Apnoea: A pilot study
Scientific title
Efficacy and tolerability of a novel adjustable mandibular advancement device (iSlpr®) for Obstructive Sleep Apnoea in adults: A pilot study
Secondary ID [1] 303270 0
Nil known
Universal Trial Number (UTN)
Trial acronym
iSlpr® Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) 320507 0
Condition category
Condition code
Respiratory 318374 318374 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, randomised sham-controlled crossover trial. Treatment order (active vs sham) will be randomised. Participants are allocated into Groups A and B according to the randomised treatment orders. Total duration of the study is 9 weeks.

-Group A: Active iSlpr® oral device will be worn for a period of 4 weeks followed by the sham oral device for a period of 4 weeks.
-Group B: Sham oral device will be worn first for a period of 4 weeks followed by the active iSlpr® oral device for a period of 4 weeks.

During the treatment period, the oral device will be worn nightly at the participant’s home, and time recorded in the compliance sleep diary when participant goes to bed and will be removed when they wake up in the morning. There is no minimum or maximum time limit for oral device wearing.

There is a one-week washout period between the two 4-week intervention periods during which the participant will not be wearing any oral device when they go to bed. Sleep time will be recorded in the compliance sleep diary during this period.

At the start of the study, personalized device fitting for participant will be overseen by a qualified dentist with expertise in mandibular advancement device fitting, during a 30-minute visit. Participants will be educated on the titration of their devices during the dental visit. Participants will be required to titrate to their maximum level of comfort over the duration of their respective 4-week treatment period. They will be instructed to wear either the active iSlpr® oral device or the sham oral device during the first 4-week period according to their randomised treatment order, and the other oral device, respectively, during the second 4-week period. Participants will also be educated on the use of the oral devices and proper cleaning technique by verbal instruction from the dentist only.

Both the active iSlpr® customized mandibular advancement device and sham device will be provided to all participants in the study at no cost.

All participants will be monitored to ensure their adherence to the interventions for the duration of the study. They are required to keep daily record of their use of the device and sleep time in the compliance sleep diary. Thirty-minute weekly follow-up phone call by the study coordinator will begin once the participant has received their oral devices after the dental device fitting to monitor adherence, to provide support/ answer queries from participants.

Participants will be permitted to retain the active iSlpr® oral device free of charge at the conclusion of the trial if deemed clinically useful by the treating sleep physician.
Intervention code [1] 319604 0
Treatment: Devices
Comparator / control treatment
Each participant is acting as their own control as it is a crossover study.
The sham oral device is a mandibular advancement device identical to the active iSlpr® oral device with the exception that it will remain in the non-titrated position and functionally unable to protrude the jaw.
Control group
Active

Outcomes
Primary outcome [1] 326356 0
Efficacy of active iSlpr® oral device as measured by the change in apnoea hypopnoea Index (AHI), as per current American Academy of Sleep Medicine (AASM) guidelines, determined by a diagnostic sleep study using polysomnography device.
Timepoint [1] 326356 0
Baseline, the end of 4 and 9 weeks (primary timepoint) post-treatment commencement
Secondary outcome [1] 391160 0
Participant acceptance assessed by the proportion of participants who continue to wear the device calculated using the study database.
Timepoint [1] 391160 0
Weekly post-treatment commencement for 9 weeks
Secondary outcome [2] 391161 0
Participant tolerability assessed by a questionnaire designed specifically for this study
Timepoint [2] 391161 0
Weekly post-treatment commencement for 9 weeks
Secondary outcome [3] 391162 0
Composite outcome: Sleep quality assessed by the standard Berlin Questionnaire and Epworth Sleepiness Scale Questionnaire, and study-specific Snoring Visual Analogue Scale and Questionnaire
Timepoint [3] 391162 0
Weekly post-treatment commencement for 9 weeks
Secondary outcome [4] 391163 0
Participant feedback on feasibility of device use assessed by a questionnaire designed specifically for this study
Timepoint [4] 391163 0
At the end of 9 weeks post-treatment commencement
Secondary outcome [5] 391164 0
Self-assessment perceived side effects assessed by a questionnaire designed specifically for this study
Timepoint [5] 391164 0
At the end of 9 weeks post-treatment commencement, 6 months post-study completion

Eligibility
Key inclusion criteria
1. New diagnosis of at least moderate OSA with an AHI of equal to or greater than 15 events per hour
2. Aged 18 years and older
3. At least two symptoms of OSA from the following:
-Snoring
-Fragmented sleep
-Witnessed apnoeas
-Daytime sleepiness
4. Willingness to provide informed consent and to participate in a 9 week trial of two novel oral appliances.
5. Proficiency in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Very severe OSA classified as an AHI of equal to or greater than 50 events per hour and/or a minimum oxygen desaturation of equal to or less than 70%.
2. Need for immediate treatment of OSA based on clinical judgement of sleep physician, including unstable comorbidities or driving risk (e.g. commercial drivers)
3. Co-existing sleep disorders or Central Sleep Apnoea
4. Regular use of sedatives or narcotics
5. Any contraindication for oral appliance therapy including poor oral hygiene, mobile teeth, temporomandibular dysfunction, other oral conditions as deemed by the dentist
6. Unstable psychiatric or psychological illness that would prevent accurate reporting
7. Pregnancy
8. Participant is unable to understand the research project.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Oral appliance design issues
Date of first participant enrolment
Anticipated
19/04/2021
Actual
16/06/2021
Date of last participant enrolment
Anticipated
Actual
20/11/2021
Date of last data collection
Anticipated
Actual
2/05/2022
Sample size
Target
24
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18522 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 32861 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 307680 0
Commercial sector/Industry
Name [1] 307680 0
BioAnalytics Holdings Pty Ltd
Country [1] 307680 0
Australia
Primary sponsor type
Individual
Name
Prof Andrew Chan
Address
Department of Respiratory and Sleep Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 308379 0
None
Name [1] 308379 0
Address [1] 308379 0
Country [1] 308379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307716 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307716 0
Level 13 Kolling Building,
Royal North Shore Hospital,
St Leonards NSW 2065
Ethics committee country [1] 307716 0
Australia
Date submitted for ethics approval [1] 307716 0
27/01/2021
Approval date [1] 307716 0
05/03/2021
Ethics approval number [1] 307716 0
2021/ETH00137

Summary
Brief summary
The study aims to assess whether a novel type of mandibular advancement device (MAD) design that does not require retention on the teeth is effective in the treatment of obstructive sleep apnoea (OSA). Specifically, the study will compare two settings (active vs sham) of the MAD. Participants that meet the selection criteria undergo a 4 week sham treatment and 4 week active treatment phase with the order being determined randomly. There is a washout period of 1 week after the initial 4 weeks of treatment. The participants will be informed of the nature of each phase at the study conclusion, i.e., the end of 9 weeks period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108250 0
Prof Andrew Chan
Address 108250 0
Department of Respiratory and Sleep Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country 108250 0
Australia
Phone 108250 0
+61 2 9463 2933
Fax 108250 0
Email 108250 0
[email protected]
Contact person for public queries
Name 108251 0
Sally McClintock
Address 108251 0
Department of Respiratory and Sleep Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country 108251 0
Australia
Phone 108251 0
+61 0402832401
Fax 108251 0
Email 108251 0
[email protected]
Contact person for scientific queries
Name 108252 0
Sally McClintock
Address 108252 0
Department of Respiratory and Sleep Medicine
Royal North Shore Hospital
St Leonards NSW 2065
Country 108252 0
Australia
Phone 108252 0
+61402832401
Fax 108252 0
Email 108252 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.