Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001730291p
Ethics application status
Not yet submitted
Date submitted
16/10/2018
Date registered
22/10/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Single centred, interventional study on abdominal breathing to eliminate/reduce sleep apnoea.
Scientific title
Can abdominal breathing inculcated in the awake state manifest continually during sleep and in turn eliminate/reduce sleep apnoea and/or reduce high levels of positive airway pressure requirements to achieve better compliance and efficacy?
Secondary ID [1] 296347 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 310066 0
Condition category
Condition code
Respiratory 308822 308822 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is interventional, employing behavioural approaches and diagnostic procedures.
The behavioural change aims to instil during the day (awake) and continue abdominal breathing by the participants during sleep.
Achievement of abdominal breathing will be attempted by instructions and training. Participant's awareness of their abdominal muscle activity will be facilitated with Biofeedback technique (ie. Thoracic and abdominal belts will be applied to the participants. Signals from these belts will be transmitted via a polysomnographic device to the computer. This will allow the patients and the researcher to view).
Diagnostic procedure via polysomnographic (PSG) sleep studies will authenticate definitive outcomes.
The interventions will be delivered by Dr Peter Keller, Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment, and staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam.
The mode of delivery will be face to face preferably in group sessions (individually if requested by participants).
Automatic Positive Airway Pressure (APAP) usage at participant’s home will be monitored via a secured web-based software. For this purpose, Automatic Positive Airway Pressure (APAP) machines with built-in modem will be used. Participants will be informed that the modem will be activated to facilitate remote monitoring. After every use the data will be sent to a cloud based Microsoft Server which will enable us to monitor usage and compliance.

Step 1 – Potential participants will be contacted over the phone and be invited to attend the information seminar.
Step 2 – The information seminar will be conducted for small groups of 5-6 participants. The seminar will be conducted at the Clinic. The duration of the seminar will be 120 mins. During the seminar attendees will be given all pertinent information, patient information booklet and consent forms.
Step 3 – Consent forms will be collected at the Clinic. The duration of this will be 10 mins per patient.
Step 4 – Consent forms will be analysed, further information/documentation required (if any) will be collected and processed. Potential participants will be notified of their enrolment (successful/unsuccessful).
Step 5 – Participants will be contacted and sleep study appointment will be made.
Step 6 – Baseline sleep study will be carried out at the Clinic. The 10 hour duration will be overnight.
Step 7 – The results of the sleep study will be discussed with the participant.
Step 8 – Participants in group 2 will undergo 60 mins of training on abdominal breathing at the Clinic. Biofeedback technique will be used to mirror participant’s abdominal breathing effort, while participants in Group 1 will not undergo any new intervention via this trial.
Step 9 – Participants in group 2 will be instructed to carryout 5 mins of abdominal breathing exercise, 5 times a day, over the next 2 weeks.
Step 10 – 60 min biofeedback tests will be carried out on participants in group 2 to monitor abdominal breathing effort at the Clinic fortnightly.
Step 11 – At the end of 55 days, a sleep study will be conducted at the Clinic to monitor the effects of participant’s abdominal breathing effort. The duration of the overnight sleep study is 10 hours.
Step 12 – The results of the sleep study will be discussed with the participants.
Step 10, 11 and 12 will be repeated two more times. The second sleep study will be carried out at the end of 115 days and the third sleep study will be conducted at the end of 175 days.
Intervention code [1] 312673 0
Treatment: Other
Comparator / control treatment
Non compliant participants will be recommended to see their Physicians for advice.
Compliant participants will be encouraged to continue with the treatment plan (use of Automatic Positive Airway Pressure device, for at least 4 hours in a 24 hour period) rendered to them by their physician.
Control group
Active

Outcomes
Primary outcome [1] 307795 0
The number of the participants with Apnoea/hypopnoea index (AHI). This will be determined by full PSG sleep studies.
Timepoint [1] 307795 0
Baseline, 55 days, 115 days and 175 days [primary timepoint] post commencement of intervention.
Secondary outcome [1] 352946 0
The pressure from the Automatic Positive Airway Pressure (APAP) device with the inculcation of abdominal breathing.
This will be assessed via polysomnographic (PSG) sleep studies along with the APAP device.
Timepoint [1] 352946 0
Baseline, 55 days, 115 days and 175 days post commencement of intervention.

Eligibility
Key inclusion criteria
People who have been medically diagnosed with mild/moderate/severe Sleep Disordered Breathing (SDB), and are on APAP therapy
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bearing in mind the duty of care responsibilities and the health safety and welfare of the participants, those who fall under the following categories will be excluded from this study, to abide by the credo of “doing no harm” inadvertently:
a. Participants below the age of 18 and above the age of 85
b. Pregnant women
c. Obstructive Sleep Apnoea (OSA) with uncontrolled or untreated cardiovascular disease.

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)
Randomised - allocation involved contacting the "off-site" holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised - Simple randomisation using coin-tossing by an independent "off-site" individual.
Once, 24 participants have been allocated into one group by random toss of a coin the other remaining participants will be allocated into the group that is not fully filled.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve our study objective, we have groups based on their Apnoea Hypopnoea Index (AHI) and their Body Mass Index (BMI).
Because these grouping will comprise participants with many variables themselves, and at variance from each other, to get meaningful and statistically significant data, we need at least 24 participants in each group.
AHI and BMI will be regularly monitored and tabulated. The data will be depicted in histograms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
7/02/2019
Actual
Date of last data collection
Anticipated
20/09/2019
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300949 0
Self funded/Unfunded
Name [1] 300949 0
Dr Peter Keller
Country [1] 300949 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Keller
Address
Breathe Eezily Pty Ltd
Suite 1A, 41-45 Rickard Road, Bankstown, NSW 2200
Country
Australia
Secondary sponsor category [1] 300525 0
None
Name [1] 300525 0
Address [1] 300525 0
Country [1] 300525 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301717 0
Bellberry Limited
Ethics committee address [1] 301717 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 301717 0
Australia
Date submitted for ethics approval [1] 301717 0
02/01/2019
Approval date [1] 301717 0
Ethics approval number [1] 301717 0

Summary
Brief summary
The study is interventional, employing behavioural approaches and diagnostic procedures.

The behavioural change aims to instil during the day (awake) and continue abdominal breathing by the participants during sleep.
The study will include instructions, training and bringing abdominal muscle awareness to participants during breathing which will be mirrored with biofeedback.
Secondly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes.
The training on the interventions will be delivered by staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment.

The mode of delivery will be face to face preferably in group sessions (individually if requested by participants), employing instructions, training, as well as remote monitoring via telephone and internet.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 87866 0
Dr Peter Keller
Address 87866 0
Breathe Eezily Pty Ltd,
Suite 1A, 41-45 Rickard Road, Bankstown, NSW 2200
Country 87866 0
Australia
Phone 87866 0
+61 414 381 061
Fax 87866 0
Email 87866 0
[email protected]
Contact person for public queries
Name 87867 0
Ms Thanusha Sothiratnam
Address 87867 0
Breathe Eezily Pty Ltd,
Suite 1A, 41-45 Rickard Road, Bankstown, NSW 2200
Country 87867 0
Australia
Phone 87867 0
+61 430 125 638
Fax 87867 0
Email 87867 0
[email protected]
Contact person for scientific queries
Name 87868 0
Dr Peter Keller
Address 87868 0
Breathe Eezily Pty Ltd,
Suite 1A, 41-45 Rickard Road, Bankstown, NSW 2200
Country 87868 0
Australia
Phone 87868 0
+61 414 381 061
Fax 87868 0
Email 87868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The outcome of the trial will be made available without revealing participant’s personal/medical information.


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.