Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001273673
Ethics application status
Not yet submitted
Date submitted
20/11/2014
Date registered
4/12/2014
Date last updated
4/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the Power Sleep Oral Device in the Management of Snoring and Sleep Apnoea
Scientific title
In adults with sleep apnoea, is the Power Sleep oral device (compared to baseline) effective in managing snoring and sleep apnoea?
Secondary ID [1] 285712 0
Nil
Universal Trial Number (UTN)
U1111-1164-3899
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnoea 293582 0
Snoring 293583 0
Condition category
Condition code
Respiratory 293866 293866 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Power Sleep device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and mild sleep apnoea. The Power Sleep device will be used for a single night whilst in bed, while simultaneously linked to an overnight polysomnography sleep study device at the participant's own home. Adherence will be measured using a single-item question "On the night that you used the device, for how much of the night did you use the device?" with responses ranging on a four point likert scale consisting of o (did not use device), 1 (some of the night), 2 (most of the night), 3 (the entire night).
Intervention code [1] 290663 0
Treatment: Devices
Comparator / control treatment
Intervention compared to baseline measures
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293653 0
Apnea Hypopnea Index, assessed by PSG (overnight polysomnography) sleep test.
Timepoint [1] 293653 0
At baseline (no device), and treatment (oral device) 1 week later.
Primary outcome [2] 293654 0
Mean minimum oxygen saturation (min SaO2), assessed by PSG (overnight polysomnography) sleep test.
Timepoint [2] 293654 0
At baseline (no device), and treatment (oral device) 1 week later.
Primary outcome [3] 293655 0
Snoring loudness (dB), assessed by PSG (overnight polysomnography) sleep test.
Timepoint [3] 293655 0
At baseline (no device), and treatment (oral device) 1 week later.
Secondary outcome [1] 311520 0
Snoring frequency (0-100%), assessed by PSG (overnight polysomnography) sleep test.
Timepoint [1] 311520 0
At baseline (no device), and treatment (oral device) 1 week later while wearing Power Sleep oral device.
Secondary outcome [2] 311521 0
Side effects (assessed by the Side-Effects Questionnaire and clinical assessment). This questionnaire is not validated, but was developed by collating the known side-effects of other existing oral devices used for sleep apnoea. Therefore, it will be accompanied by a clinical assessment to ascertain and record any additional or unexpected side-effects. Examples of possible side effects include: dry mouth, excessive salivation, temporomandibular symptoms (pain, clicking, limited opening), muscle spasm or stiffness, altered occlusion (bite), tooth pain, mobile teeth, broken teeth, biting of lips or cheeks mouth ulcers, periodontal problems, root resorption, muscle spasms, difficulty getting back to sleep after waking to go to toilet, issues with retention of device, and poor adherence.
Timepoint [2] 311521 0
Within 24 hours following sleep device intervention.
Secondary outcome [3] 311522 0
Comfort level (assessed by the Sleep Device Questionnaire)
Timepoint [3] 311522 0
Within 24 hours following sleep device intervention.
Secondary outcome [4] 311523 0
Adherence (assessed by the Sleep Device Questionnaire)
Timepoint [4] 311523 0
Within 24 hours following sleep device intervention.

Eligibility
Key inclusion criteria
Apnea Hypopnea Index-Total (AHI-total) score of five (5) or greater (assessed by overnight PSG home sleep study). This includes participants ranging from mild to severe in severity of sleep apnoea.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cardiovascular disease (untreated hypertension acceptable);
Upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy;
Dental pathology such as infection, abscess in bone, tumour, cracked teeth, and severe dental decay;
Inability to tolerate oral device due to oral or psychological condition;
Pregnant/Breast Feeding;
Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non-compliance to medical regimens, or unwillingness to comply with study requirements;
Known widespread allergy or hypersensitivity (Atopia).

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)
Participants previously diagnosed with sleep apnoea within the last 15 years were invited to participate in the study. All participants meeting inclusion/exclusion criteria will be assigned to both baseline and intervention conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants meeting inclusion/exclusion criteria will be assigned to both baseline and intervention conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures t-test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/12/2014
Actual
Date of last participant enrolment
Anticipated
22/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290286 0
Government body
Name [1] 290286 0
Commercialisation Australia
Country [1] 290286 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jack Gerschman
Address
Melbourne Medical Centre, Suite 5, Level 3, 517 St Kilda Road, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 288999 0
Individual
Name [1] 288999 0
Joel Gerschman
Address [1] 288999 0
Melbourne Medical Centre, Suite 5, Level 3, 517 St Kilda Road, Melbourne, Victoria 3004
Country [1] 288999 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291996 0
Bellberry Limited
Ethics committee address [1] 291996 0
129 Glen Osmond Road, Eastwood, South Australia 5063
Ethics committee country [1] 291996 0
Australia
Date submitted for ethics approval [1] 291996 0
19/11/2014
Approval date [1] 291996 0
Ethics approval number [1] 291996 0

Summary
Brief summary
Latest research demonstrates that up to 40 million Americans (17%), and 4 million Australians (17%) suffer from snoring and/or Obstructive Sleep Apnoea (Kryger, Roth, Rement Principles and Pracice of Sleep Medicine, 5th Ed.). Nevertheless, only a small percentage have received treatment (5% in America and less than 1% in Australia; American Society of Sleep Medicine, USA, 2014). Current treatments are costly, time-consuming and difficult to tolerate. The Power Sleep (PS) oral device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and sleep apnoea. This product has the potential to deliver a clinically effective outcome while reducing cost and increasing comfort levels. The current study aims to examine the efficacy and safety of the Power Sleep (PS) oral device in the management of snoring and sleep apnoea. A pre-post test design involving measures at baseline and using the oral device will be employed using approximately 30 participants aged 18-65 with sleep apnoea. It is hypothesized that the Power Sleep (PS) oral device will have a salutatory effect compared to baseline measures on: (a) snoring loudness; (b) snoring frequency; (c) Apnoea Hypopnea Index-REM (AHI-REM); (d) Apnoea Hypopnea Index-Total (AHI-Total); and (e) mean minimum oxygen saturation (min SaO2).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52954 0
A/Prof Jack Gerschman
Address 52954 0
Melbourne Medical Centre, Suite 5, Level 3, 517 St Kilda Road, Melbourne, Victoria 3004.
Country 52954 0
Australia
Phone 52954 0
+61 3 9867 8522
Fax 52954 0
Email 52954 0
[email protected]
Contact person for public queries
Name 52955 0
A/Prof Jack Gerschman
Address 52955 0
Melbourne Medical Centre, Suite 5, Level 3, 517 St Kilda Road, Melbourne, Victoria 3004.
Country 52955 0
Australia
Phone 52955 0
+61 3 9867 8522
Fax 52955 0
Email 52955 0
[email protected]
Contact person for scientific queries
Name 52956 0
A/Prof Jack Gerschman
Address 52956 0
Melbourne Medical Centre, Suite 5, Level 3, 517 St Kilda Road, Melbourne, Victoria 3004.
Country 52956 0
Australia
Phone 52956 0
+61 3 9867 8522
Fax 52956 0
Email 52956 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23367Clinical study report-999999  
23368Ethical approval-999999  

Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3810Basic resultsNo 367474-(Uploaded-21-11-2018-09-46-25)-Basic results summary.docx
3982Plain language summaryNo The overall purpose of this study was to investiga... [More Details]

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