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
Trial registered on ANZCTR


Registration number
ACTRN12614000905662
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
25/08/2014
Date last updated
25/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, double blind, placebo-controlled trial to assess the efficacy of LipZip in reducing mouth breathing on continuous positive airway pressure (CPAP) treatment.
Scientific title
A randomized, double-blind, placebo-controlled, crossover study to assess the efficacy of LipZip oral adhesive gel in reducing mouth breathing on continuous positive airway pressure (CPAP) treatment in patients with obstructive sleep apnea (OSA).
Secondary ID [1] 284277 0
None
Universal Trial Number (UTN)
U1111-1154-7636
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 291409 0
Condition category
Condition code
Respiratory 291770 291770 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that will be used in this trial is a LipZip oral adhesive gel to reduce mouth breathing during CPAP treatment in patients with obstructive sleep apnea. LipZip is comprised of 54.7% purified water, 12% Gantrez MZ 955, 12% Kollidon 90F, 10% ethanol, 4.5% Dimethicone 200, 2% citric acid anhydrous, 2% xantham gum, 1.5% Sepigel 305, 1% aerosil 200, traces of potassium sorbate and disodium edetate. Gantrez MZ 955 possesses thickening and adhesive properties and is registered for use in oral care. Kollidon 90 F is used as a binding agent. Dimethicone is a medium silicon oil approved for personal care products.
A 2mm to 3mm thick single line of LipZip gel will be applied to two-thirds of the lower lip where it comes into contact with the upper lip. It is applied once nightly prior to going to bed. Treatment adherence is assessed by self report diary and gel return.
1. Mouth breathing is a common problem during CPAP treatment. It is known to contribute to low adherence to treatment. Patients who have problems of mouthbreathing will be recruited.
2. Participants will be randomized between the active and non-active group. They will be on using the oral gel for 2 weeks for each group that they are assigned.
3. There will be a washout period of 2 weeks.
4.Participants will crossover to the next treatment group.
Intervention code [1] 288990 0
Treatment: Devices
Comparator / control treatment
Placebo oral adhesive gel will be made of Vaseline and Castor Oil.
Control group
Placebo

Outcomes
Primary outcome [1] 291733 0
Reduction in mouth breathing as measured by the leak data from the CPAP device as assessed in all participants at both timepoints
Timepoint [1] 291733 0
at 2 and 6 weeks after randomisation
Secondary outcome [1] 307364 0
Visual Analogue Scale responses on the ease of use of LipZip and is assessed in all participants at both timepoints
Timepoint [1] 307364 0
at 2 and 6 weeks after randomisation
Secondary outcome [2] 308787 0
CPAP adherence as measured by average CPAP use on LipZip, assessed in all participants at both timepoints, by downloading the memory card in the device.
Timepoint [2] 308787 0
at 2 and 6 weeks after randomization

Eligibility
Key inclusion criteria
1. Patients diagnosed with obstructive sleep apnea with a minimum Apnea Hypopnea Index (AHI) of 15 events/hour. 2. Patients currently on CPAP treatment with known history of mouth breathing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients on auto-adjusting PAP machine.
2. Patients with retrognathia.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5910 0
New Zealand
State/province [1] 5910 0
Auckland

Funding & Sponsors
Funding source category [1] 288926 0
Other
Name [1] 288926 0
New Zealand Respiratory and Sleep Institute
Country [1] 288926 0
New Zealand
Primary sponsor type
Other
Name
NZ Respiratory and Sleep Institute
Address
PO Box 109 409
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 287618 0
None
Name [1] 287618 0
Address [1] 287618 0
Country [1] 287618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290753 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 290753 0
Ethics committee country [1] 290753 0
New Zealand
Date submitted for ethics approval [1] 290753 0
27/03/2014
Approval date [1] 290753 0
11/08/2014
Ethics approval number [1] 290753 0

Summary
Brief summary
Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. This study is aimed to assess the efficacy of LipZip in reducing mouth breathing on CPAP treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46966 0
Dr Andrew Veale
Address 46966 0
NZ Respiratory & Sleep Institute
PO Box 109-409
Newmarket
Auckland 1149
Country 46966 0
New Zealand
Phone 46966 0
+6496385255
Fax 46966 0
Email 46966 0
[email protected]
Contact person for public queries
Name 46967 0
Dr Andrew Veale
Address 46967 0
NZ Respiratory & Sleep Institute
PO Box 109-409
Newmarket
Auckland 1149
Country 46967 0
New Zealand
Phone 46967 0
+6496385255
Fax 46967 0
Email 46967 0
[email protected]
Contact person for scientific queries
Name 46968 0
Dr Andrew Veale
Address 46968 0
NZ Respiratory & Sleep Institute
PO Box 109-409
Newmarket
Auckland 1149
Country 46968 0
New Zealand
Phone 46968 0
+6496385255
Fax 46968 0
Email 46968 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.