Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000694213p
Ethics application status
Not yet submitted
Date submitted
14/04/2018
Date registered
27/04/2018
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
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 during sleep eliminate/reduce sleep apnoea and/or reduce high levels of positive airway pressure requirements to achieve better compliance and efficacy?
Secondary ID [1] 294598 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 (SDB) 307402 0
Sleep Apnoea 307560 0
Condition category
Condition code
Respiratory 306511 306511 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is interventional, employing devices, behavioural approaches and diagnostic procedures.
The behavioural change aims to instil and continue abdominal breathing by the participants during sleep.
Firstly this will be attempted by instructions, training and participant's awareness of their abdominal muscle activity. This will be facilitated with Biofeedback.
Secondly supporting activity via Electrical Muscle Stimulator (EMS) and Automatic Positive Airway Pressure (APAP) devices may need to be utilised (where ever APAP is used, it will be used with a pressure setting of 4-20 cmH2O with humidification).
Thirdly 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), employing instructions, training and devices.
Abdominal breathing practice undertaken at participant's own home will be monitored via calls/SMS. APAP usage at participant’s home will be monitored via a secured web-based software. For this purpose, 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.
Duration 6 weeks approx (Step 4 mentioned below will be undertaken concurrently, while other steps will be sequential):
Step 1 - Introductory information session - Day 1 - 90minutes - in the Clinic
Step 2 - Overnight PSG Sleep Study to establish base line - Night 1 – 8 to 10 hours - in the Clinic
Step 3 - Abdominal breathing training with Biofeedback - Day 2 - 1 hour - in the Clinic
Step 4 - Abdominal breathing practice - Day 2 to Day 17 - 5 X 5 minutes sessions per day for 2 weeks - in the participants' own home
Step 5 - Muscle Memory Retention (MMR) establishment monitoring via Biofeedback - Day 18 - 1 hour - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 6 - If MMR is established in point 5, Abdominal breathing practice will be continued till their next PSG - Day 19 to Day 25 - 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 7 - If MMR is not established in point 5, EMS and APAP will be introduced for assistance to embrace abdominal breathing - Day 19 - 2 hours - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 8 - If MMR is established in point 7, Abdominal breathing practice will be continued till their next PSG - Day 20 to Day 26 - 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 9 - If MMR is not established in point 7, further assistance (additional Biofeedback sessions with EMS, +/- APAP) will be offered - Day 20 to Day 26 - 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 10 - Overnight PSG Sleep Study will be carried out to see if MMR can be retained during sleep - Day 20 to Day 26 - Night 2 – 8 to 10 hours - in the Clinic
Step 11 - If MMR is established in point 10, Abdominal breathing practice will be continued between their long term Biofeedback monitoring sessions and Overnight PSG Sleep Study - Day 27 to Day 47 - 30 minute (Biofeedback monitoring sessions) - in the Clinic and Night 3 to Night 8 – 8 to 10 hours (Overnight PSG Sleep Study) - in the Clinic along with 5 X 5 minutes sessions per day till the end of the 5 yr study period - in the participants' own home
Step 12 - If MMR is not established in point 10, participants will have full PSG with EMS - Night 3 – 8 to 10 hours - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 13 - 4 to 5 fortnightly sessions with EMS and Biofeedback till MMR is confirmed with PSG - Day 27 to Day 32 - 30 minute - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 14 - In point 13, if MMR is not established, Participants will be asked to use APAP in their own homes - compliance will be monitored remotely - Night 4 to Night 34 - Greater than 4 hours/night - in the participants' own home along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home
Step 15 - Full PSG with APAP after the 4 weeks - Night 35 – 8 to 10 hours - in the Clinic
Step 16 - If desirable, APAP will be used in conjunction with EMS to try and reduce APAP pressure and achieve compliance - Night 36 - 8 to 10 hours - in the Clinic
Step 17 - PSG and Biofeedback sessions will be carried out in the Clinic to monitor compliance throughout the trial period
Step 18 - If the compliance is below medically accepted standards, participants will be offered to join the stage at which they demonstrated MMR and continue the process from there
Step 19 - At all stages, participants' GPs and Specialists will be apprised of their progress
Intervention code [1] 300895 0
Treatment: Other
Intervention code [2] 300896 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305518 0
The number of the participants with a minimum of 10% reduction of Apnoea/hypopnoea index (AHI). This will be determined by a full PSG sleep study.
Timepoint [1] 305518 0
Baseline, 6 weeks post commencement of intervention.
Secondary outcome [1] 345571 0
The number of participants with a minimum of 10% increase in the abdominal effort. This will be determined by a full PSG sleep study.
Timepoint [1] 345571 0
Baseline, 6 weeks post commencement of intervention.

Eligibility
Key inclusion criteria
1. People who have experienced disturbed sleep patterns,
2. People who have been witnessed to have apnoeic episodes,
3. People who have been medically diagnosed with mild/moderate/severe Sleep Disordered Breathing (SDB), on treatment but not compliant partially/fully.
Minimum age
15 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be PPs with pacemaker, implantable cardioverter defibrillator (ICD), on dialysis, pregnancy or lactation, current participation in another clinical trial, medication usage that could influence respiration or sleep (eg, regular use of sedatives, heavy alcohol consumption), OSA with uncontrolled or untreated cardiovascular disease, severe somatic or psychiatric disorders those who were tested positive for narcolepsy/cataplexy, idiopathic somnolence, severe somatic or psychiatric disorders, children and young people, People highly dependent on medical care, people who may be involved in illegal activities, people with cognitive impairment and intellectual disability or a mental illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
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 large numbers to smooth out the inherent variables.
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
26/06/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
10/08/2022
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299218 0
Self funded/Unfunded
Name [1] 299218 0
Dr Peter Keller
Country [1] 299218 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] 298481 0
None
Name [1] 298481 0
N/A
Address [1] 298481 0
N/A
Country [1] 298481 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300138 0
Bellberry Limited
Ethics committee address [1] 300138 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300138 0
Date submitted for ethics approval [1] 300138 0
30/04/2018
Approval date [1] 300138 0
Ethics approval number [1] 300138 0

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

The behavioural change aims to instil and continue abdominal breathing by the participants during sleep.
Firstly this will be attempted by instructions, training, participant's abdominal muscle awareness during breathing, This will be assisted with Biofeedback.
Secondly supporting activity via EMS and APAP devices may need to be utilised.
Thirdly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes.

The interventions will delivered by themselves and 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 and devices, as well as remote monitoring via telephone and internet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82682 0
Dr Peter Keller
Address 82682 0
Breathe Eezily Pty Ltd
Suite 1A
41-45 Rickard Road
Bankstown
NSW 2200
Country 82682 0
Australia
Phone 82682 0
+61 414 381 061
Fax 82682 0
Email 82682 0
[email protected]
Contact person for public queries
Name 82683 0
Ms Thanusha Sothiratnam
Address 82683 0
Breathe Eezily Pty Ltd
Suite 1A
41-45 Rickard Road
Bankstown
NSW 2200
Country 82683 0
Australia
Phone 82683 0
+61 430 125 638
Fax 82683 0
Email 82683 0
[email protected]
Contact person for scientific queries
Name 82684 0
Dr Peter Keller
Address 82684 0
Breathe Eezily Pty Ltd
Suite 1A
41-45 Rickard Road
Bankstown
NSW 2200
Country 82684 0
Australia
Phone 82684 0
+61 414 381 061
Fax 82684 0
Email 82684 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


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.