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Trial registered on ANZCTR


Registration number
ACTRN12612000992808
Ethics application status
Approved
Date submitted
5/09/2012
Date registered
17/09/2012
Date last updated
17/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acupuncture and Obstructive Sleep Apnoea
Scientific title
The effect of acupuncture on upper airway function in obstructive sleep apnoea
Secondary ID [1] 281171 0
Nil
Universal Trial Number (UTN)
U1111-1134-3349
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 287341 0
Condition category
Condition code
Respiratory 287675 287675 0 0
Sleep apnoea
Alternative and Complementary Medicine 287680 287680 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture:
Study Duration: the whole study will take 15 weeks starting from the screening, and including the baseline and end measurement sessions as well as twelve acupuncture treatment sessions.
Intervention: each acupuncture treatment session will be one hour in duration with a total of 12 treatment sessions (2 x bi-weekly treatments for two weeks, 1 x weekly treatments for the next 6 weeks and finally 2 x fortnightly treatments for the next four weeks).
Mode of administration: The acupuncture treatment involves single-use disposable acupuncture needles that vary between 13-40mm in length and 0.18-0.25mm in diameter. The points of application will vary depending on the stage of treatment but will be points that regulate activity of the respiratory tract, and tonify the Spleen, Kidneys and Lungs.
Intervention code [1] 285619 0
Treatment: Other
Comparator / control treatment
Sham Acupuncture:
Study Duration: the whole study will take 15 weeks starting from the screening, and including the baseline and end measurement sessions as well as twelve acupuncture treatment sessions.
Sham Intervention: each session will be one hour long in duration with a total of 12 sham treatment sessions (2 x bi-weekly treatments for two weeks, 1 x weekly treatment for the next 6 weeks and finally 2 x fortnightly treatments for the next four weeks).
Mode of administration: The sham acupuncture will be sham laser acupuncture treatment in which the diode has been removed from the laser to ensure that the treatment is biologically inactive. The points used in treatment will be identical to the points used in the needle acupuncture treatments. Patients will be told that they are receiving laser acupuncture. Participants will be aware before consenting that some participants will receive a placebo treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 287916 0
Score on the Apnoea/Hypopnoea Index which is a measure of the average number of respiratory events experienced per hour of sleep as assessed during the baseline 1 night polysomnography.
Timepoint [1] 287916 0
at baseline and at 13 weeks after intervention commencement
Primary outcome [2] 287917 0
Mean daytime sleepiness as measured by the Epworth Sleepiness Scale
Timepoint [2] 287917 0
at screening and at 13 weeks after intervention commencement
Secondary outcome [1] 299051 0
Activity of the genioglossus muscle both during wakefulness and during sleep in response to airway occlusions as measured via intramuscular electrode wires inserted into the genioglossus muscle
Timepoint [1] 299051 0
at baseline and at 13 weeks after intervention commencement
Secondary outcome [2] 299052 0
Mean arousal threshold defined as the maximal respiratory effort required to arouse from sleep in order to re-open the airway thereby terminating an occlusion. This is taken as the average pressure in the throat just prior to termination of respiratory events. A pressure tipped catheter will be advanced through the nasal cavity to the back of the throat to take this measure.
Timepoint [2] 299052 0
at baseline and at 13 weeks after intervention commencement
Secondary outcome [3] 299053 0
Upper Airway Resistance during wakefulness. Resistance is measured as a function of nasal to epiglottic pressure as measured by an epiglottic pressure catheter and a pressure catheter at the back of the nasal chonae.
Timepoint [3] 299053 0
at baseline and at 13 weeks after intervention commencement

Eligibility
Key inclusion criteria
Mild to moderate OSA (AHI between 5 and 30)
Not currently receiving treatment for obstructive sleep apnoea
Acupuncture naive (as defined as not having previously experienced acupuncture treatment)
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excessive daytime sleepiness.

Pregnant women.

Individuals dependent on a carer or guardian.

Individuals unable by reason of cognitive impairment, or inadequate English language skill to give informed consent.

Individuals with concurrent sleep disorders other than OSA or a co-morbid condition that is a significant threat to mortality or significantly alters respiratory or cardiovascular anatomy or physiology (e.g., patients who have had an acute cardiac or cerebral event in the previous 3 month, or patients with cardiac disease and oxygen saturation less than 90% for more than 10 minutes during sleep).

Individuals for whom withholding treatment would lead to a significant risk to them or the general population (e.g., bus/taxi drivers or heavy machinery operators, those with severe daytime sleepiness - defined as Epworth Sleepiness Score >16, or those in whom, in the opinion of their treating physician, it is unsafe to withold definitive treatment for a period of 15 weeks).

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)
Participants will be randomly assigned to either the treatment or placebo groups. Allocation concealment will be ensured through use of sealed, consecutively numbered opaque envelopes. A master document with information about which treatment group each participant was involved in will be kept in electronic format on a secure computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will involve randomly allocating all participants to the two groups according to a computer-generated random number schedule (www.randomizer.org) that will be performed by an individual that is not a member of the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
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)

Funding & Sponsors
Funding source category [1] 285945 0
University
Name [1] 285945 0
The University of Melbourne
Address [1] 285945 0
12th Floor Redmond Barry Building
The University of Melbourne
Parkville, 3010
Victoria
Country [1] 285945 0
Australia
Primary sponsor type
Individual
Name
Dr. Amy Jordan
Address
Institute for Breathing and Sleep
First floor, Bowen Centre
Austin Health
145 Studley Road
Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 284769 0
Hospital
Name [1] 284769 0
Austin Health
Address [1] 284769 0
First Floor, Bowen Centre
Austin Health
145 Studley Road
Heidelberg, Victoria, 3084
Country [1] 284769 0
Australia
Other collaborator category [1] 277053 0
Individual
Name [1] 277053 0
Dr. Fergal O'Donoghue
Address [1] 277053 0
Department of Respiratory and Sleep Medicine
First Floor, Bowen Centre
Austin Health
145 Studley Road
Heidelberg, Victoria, 3084
Country [1] 277053 0
Australia
Other collaborator category [2] 277054 0
Individual
Name [2] 277054 0
Prof. John Trinder
Address [2] 277054 0
The University of Melbourne
12th Floor Redmond Barry Building,
Parkville, Victoria, 3010
Country [2] 277054 0
Australia
Other collaborator category [3] 277055 0
Individual
Name [3] 277055 0
Prof. Charlie Xue
Address [3] 277055 0
RMIT University
Building 201, Level 2, Room 06
Bundoora, Victoria, 3083
Country [3] 277055 0
Australia
Other collaborator category [4] 277056 0
Individual
Name [4] 277056 0
Peter Rochford
Address [4] 277056 0
Institute for Breathing and Sleep
First Floor, Bowen Centre
Austin Health
145 Studley Road
Heidelberg, Victoria, 3084
Country [4] 277056 0
Australia
Other collaborator category [5] 277057 0
Individual
Name [5] 277057 0
Therese Thornton
Address [5] 277057 0
Room 922 Redmond Barry Building,
The University of Melbourne,
Parkville, Victoria, 3000
Country [5] 277057 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287980 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 287980 0
Office for Research
Level 6 HSB,
Austin Health,
Studley Road,
Heidelberg, Victoria, 3084
Ethics committee country [1] 287980 0
Australia
Date submitted for ethics approval [1] 287980 0
29/08/2012
Approval date [1] 287980 0
04/09/2012
Ethics approval number [1] 287980 0
H2012/04654

Summary
Brief summary
Obstructive sleep apnoea (OSA) is a disorder characterised by repetitive obstruction of the throat during sleep. People who suffer from OSA have increased risk of heart disease and are often very tired during the daytime. Currently, continuous positive airway pressure (CPAP) is the most common treatment for OSA because it treats the disorder in almost all patients. Many patients, however, do not like using CPAP for several reasons (for example it is bulky, or is uncomfortable), and therefore choose not to use it. For this reason, we wish to find an alternative treatment that is effective and well tolerated by patients.
A recent research paper has suggested that acupuncture can lower the severity of OSA. However, the authors did not investigate how acupuncture caused the change in OSA severity. Our study aims to 1) see whether acupuncture treats OSA, and 2) try and work out how acupuncture is improving the severity of OSA. It is hypothesized that patients will experience fewer respiratory events and experience less daytime sleepiness after twelve treatments of acupuncture, but that placebo acupuncture will have no effect on the severity of OSA or sleepiness. It is also hypothesized that for those patients who experience reductions in the severity of their OSA symptoms will show changes in the activity of the airway muscles, changes in the resistance to airflow in their throat and changes in the amount of effort required to wake them from sleep while they are having a respiratory event.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34670 0
Address 34670 0
Country 34670 0
Phone 34670 0
Fax 34670 0
Email 34670 0
Contact person for public queries
Name 17917 0
Therese Thornton
Address 17917 0
Room 922 Redmond Barry Building,
The University of Melbourne,
Parkville, Victoria, 3010
Country 17917 0
Australia
Phone 17917 0
+61 3 83444911
Fax 17917 0
Email 17917 0
therese.thornton@unimelb.edu.au
Contact person for scientific queries
Name 8845 0
Dr. Amy Jordan
Address 8845 0
Institute for Breathing and Sleep
First Floor, Bowen Centre
Austin Health
145 Studley Road
Heidelberg, Victoria, 3084.
Country 8845 0
Australia
Phone 8845 0
+61 3 83446357
Fax 8845 0
Email 8845 0
ajordan@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results