Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
Scientific title
The efficacy of an oral rehabilitation apparatus, the Lip Trainer, on sleep apnea and sleep quality
Query!
Secondary ID [1]
282593
0
CTN: 145/2012
Therapeutic Goods Administration, Australian Government
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sleep apnea
289284
0
Query!
Sleep quality
289285
0
Query!
lip muscle strength
289286
0
Query!
Condition category
Condition code
Respiratory
289608
289608
0
0
Query!
Sleep apnoea
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
287261
0
Treatment: Devices
Query!
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.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
289700
0
Apneic-hypopneic index (AHI) - determined by LS-100 Sleep monitoring system (Fukuda Denshi, Tokyo).
Query!
Assessment method [1]
289700
0
Query!
Timepoint [1]
289700
0
At baseline, 4 & 8 weeks post-lip muscle training.
Query!
Primary outcome [2]
289721
0
Lip closure force (lip muscle strength) - determined by Lip De Cum (Cosmo Instruments, Tokyo, Japan).
Query!
Assessment method [2]
289721
0
Query!
Timepoint [2]
289721
0
At baseline, 4 & 8 weeks post-lip muscle training.
Query!
Secondary outcome [1]
303050
0
Sleep quality - determined by Actiwatch 2 (Philips Respironics, Murrysville, PA, USA).
Query!
Assessment method [1]
303050
0
Query!
Timepoint [1]
303050
0
At baseline, 4 & 8 weeks post-lip muscle training.
Query!
Eligibility
Key inclusion criteria
Diagnosis of sleep apnea, Apneic-hypopneic index (AHI)>5
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
50
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Persons with:
-Missing teeth
-Moderate high blood pressure (160/100mmHg)
-Cardiovascular or respiratory conditions (COPD, heart diseases etc), diabetes, metabolic syndrome
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
25/09/2012
Query!
Actual
25/09/2012
Query!
Date of last participant enrolment
Anticipated
1/02/2013
Query!
Actual
8/01/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
44
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment postcode(s) [1]
6927
0
2141 - Lidcombe
Query!
Funding & Sponsors
Funding source category [1]
287375
0
Self funded/Unfunded
Query!
Name [1]
287375
0
A/Prof Chin Moi Chow
Query!
Address [1]
287375
0
Discipline of Exercise and Sport Science
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Query!
Country [1]
287375
0
Australia
Query!
Funding source category [2]
287394
0
Self funded/Unfunded
Query!
Name [2]
287394
0
Dr Hiroshi Suzuki
Query!
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
Query!
Country [2]
287394
0
Japan
Query!
Primary sponsor type
University
Query!
Name
The University of Sydney
Query!
Address
The University of Sydney NSW 2006 Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286121
0
University
Query!
Name [1]
286121
0
The University of Sydney
Query!
Address [1]
286121
0
The University of Sydney
NSW 2006
Australia
Query!
Country [1]
286121
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289350
0
Human Research Ethics Committee
Query!
Ethics committee address [1]
289350
0
The University of Sydney
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006
Query!
Ethics committee country [1]
289350
0
Australia
Query!
Date submitted for ethics approval [1]
289350
0
Query!
Approval date [1]
289350
0
04/07/2012
Query!
Ethics approval number [1]
289350
0
14541
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
40426
0
A/Prof Chin Moi Chow
Query!
Address
40426
0
Discipline of Exercise and Sport Science
Delta Sleep Research Unit
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Query!
Country
40426
0
Australia
Query!
Phone
40426
0
+61 2 9351 9332
Query!
Fax
40426
0
Query!
Email
40426
0
[email protected]
Query!
Contact person for public queries
Name
40427
0
A/Prof Chin Moi Chow
Query!
Address
40427
0
Discipline of Exercise and Sport Science
Delta Sleep Research Unit
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Query!
Country
40427
0
Australia
Query!
Phone
40427
0
+61 2 9351 9332
Query!
Fax
40427
0
Query!
Email
40427
0
[email protected]
Query!
Contact person for scientific queries
Name
40428
0
A/Prof Chin Moi Chow
Query!
Address
40428
0
Discipline of Exercise and Sport Science
Delta Sleep Research Unit
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Query!
Country
40428
0
Australia
Query!
Phone
40428
0
+61 2 9351 9332
Query!
Fax
40428
0
Query!
Email
40428
0
[email protected]
Query!
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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF