The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000632796
Ethics application status
Approved
Date submitted
29/05/2013
Date registered
5/06/2013
Date last updated
4/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lip muscle strength training, sleep apnea and sleep quality
Scientific title
The efficacy of an oral rehabilitation apparatus, the Lip Trainer, on sleep apnea and sleep quality
Secondary ID [1] 282593 0
CTN: 145/2012
Therapeutic Goods Administration, Australian Government
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep apnea 289284 0
Sleep quality 289285 0
lip muscle strength 289286 0
Condition category
Condition code
Respiratory 289608 289608 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lip muscle training.
Participants will undergo lip muscle training for 3 minutes twice daily, 4 times per week for 8 weeks. All measures will be assessed at baseline, and at 4 & 8 weeks post-lip muscle training. A training log is used to monitor participant compliance.
The Patakara (registered trade mark) (DENTAL YOUME, Tokyo Japan)(http://www.liptrainer.com/main/specifications.htm) Lip Trainer (mouth piece) contains both flexible plastic and rubber, and uses the resilience of these materials to directly condition the oral muscles to increase their strength. The device is placed between the upper and lower lips. The user closes the lips firmly onto the device and maintains this state for three minutes. The notches come together at this time and the teeth do not make contact.
Intervention code [1] 287261 0
Treatment: Devices
Comparator / control treatment
SHAM control - A paediatric Lip Trainer is used. This mouth piece offers minimal conditioning effect and has been shown to produce minimal effect on muscle strength gain.

Participants will undergo training 3 minutes twice daily, 4 times per week for 8 weeks. All measures will be assessed at baseline, and at 4 & 8 weeks post-lip muscle training. A training log is used to monitor participant compliance.

The paediatric Patakara (registered trade mark) (DENTAL YOUME, Tokyo Japan)(http://www.liptrainer.com/main/specifications.htm) Lip Trainer (mouth piece) contains both flexible plastic and rubber, and uses the resilience of these materials to directly condition the oral muscles to increase their strength. The device is placed between the upper and lower lips. The user closes the lips firmly onto the device and maintains this state for three minutes. The notches come together at this time and the teeth do not make contact.
Control group
Placebo

Outcomes
Primary outcome [1] 289700 0
Apneic-hypopneic index (AHI) - determined by LS-100 Sleep monitoring system (Fukuda Denshi, Tokyo).
Timepoint [1] 289700 0
At baseline, 4 & 8 weeks post-lip muscle training.
Primary outcome [2] 289721 0
Lip closure force (lip muscle strength) - determined by Lip De Cum (Cosmo Instruments, Tokyo, Japan).
Timepoint [2] 289721 0
At baseline, 4 & 8 weeks post-lip muscle training.
Secondary outcome [1] 303050 0
Sleep quality - determined by Actiwatch 2 (Philips Respironics, Murrysville, PA, USA).
Timepoint [1] 303050 0
At baseline, 4 & 8 weeks post-lip muscle training.

Eligibility
Key inclusion criteria
Diagnosis of sleep apnea, Apneic-hypopneic index (AHI)>5
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Persons with:
-Missing teeth
-Moderate high blood pressure (160/100mmHg)
-Cardiovascular or respiratory conditions (COPD, heart diseases etc), diabetes, metabolic syndrome

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)
Telephone screening regarding general health status, followed by sleep apnea screening.
Healthy volunteers recruited for this study will undergo a screening test to identify those with or without sleep apnea. Individuals with sleep apnea will have an Apneic Hypopneic index (AHI > 5). Both groups will then be randomly allocated to either the control arm (SHAM resistance lip muscle training) or the intervention group (with resistance lip muscle training) in a 2x2 study design. Randomisation by sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We estimate that n=22 per group will allow us to observe differences in the lip closure force following lip muscle training. The estimation was based on an effect size of 1.1 (at alpha=0.05 and beta=0.8) for a mean LCF difference of 2.09 +/- 1.9 N (pilot study).

A two-way repeated measures ANOVA will be applied to test the differences in normally distributed sleep variables between groups. For skewed data, the Mann-Whitney U Test will be used. A Pearson’s correlation test will be used to explore the relationship between observed variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6927 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 287375 0
Self funded/Unfunded
Name [1] 287375 0
A/Prof Chin Moi Chow
Address [1] 287375 0
Discipline of Exercise and Sport Science
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country [1] 287375 0
Australia
Funding source category [2] 287394 0
Self funded/Unfunded
Name [2] 287394 0
Dr Hiroshi Suzuki
Address [2] 287394 0
Nihon University School of dentistry at Matsudo Department of Oral function and Rehabilitation
2-870-1 Sakae-cho-nishi, Matsudo-shi,
Chiba 271-8587

Country [2] 287394 0
Japan
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 286121 0
University
Name [1] 286121 0
The University of Sydney
Address [1] 286121 0
The University of Sydney
NSW 2006
Australia
Country [1] 286121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289350 0
Human Research Ethics Committee
Ethics committee address [1] 289350 0
The University of Sydney
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006
Ethics committee country [1] 289350 0
Australia
Date submitted for ethics approval [1] 289350 0
Approval date [1] 289350 0
04/07/2012
Ethics approval number [1] 289350 0
14541

Summary
Brief summary
The study proposes that lip muscle strength training using the Lip Trainer, The Patakara 'Registered Trademark' (DENTAL YOUME , Tokyo Japan), will improve labial closure force through strengthening of the orbicularis oris (lip muscle), and will reduce snoring and sleep apnea resulting in improved sleep quality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40426 0
A/Prof Chin Moi Chow
Address 40426 0
Discipline of Exercise and Sport Science
Delta Sleep Research Unit
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 40426 0
Australia
Phone 40426 0
+61 2 9351 9332
Fax 40426 0
Email 40426 0
chin-moi.chow@sydney.edu.au
Contact person for public queries
Name 40427 0
A/Prof Chin Moi Chow
Address 40427 0
Discipline of Exercise and Sport Science
Delta Sleep Research Unit
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 40427 0
Australia
Phone 40427 0
+61 2 9351 9332
Fax 40427 0
Email 40427 0
chin-moi.chow@sydney.edu.au
Contact person for scientific queries
Name 40428 0
A/Prof Chin Moi Chow
Address 40428 0
Discipline of Exercise and Sport Science
Delta Sleep Research Unit
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 40428 0
Australia
Phone 40428 0
+61 2 9351 9332
Fax 40428 0
Email 40428 0
chin-moi.chow@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary