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Trial registered on ANZCTR


Registration number
ACTRN12622001518752
Ethics application status
Approved
Date submitted
31/10/2022
Date registered
6/12/2022
Date last updated
6/12/2022
Date data sharing statement initially provided
6/12/2022
Date results provided
6/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of a novel obstructive sleep apnea therapeutic method
Scientific title
An investigation into the effect of a novel obstructive sleep apnea therapeutic method on the apnea-hypopnea index.
Secondary ID [1] 308082 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 327771 0
Condition category
Condition code
Respiratory 324841 324841 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinical trials was supervised by the principle investigator. The data was collected by the Co investigator and the sponsor team.

This trial involved overnight sleep studies, two non consecutive nights, run between the hours of 8pm to 8am for four to eight hours, depending on the duration of the participants sleep.

During the first sleep study, the participants used usual CPAP therapy at lower than normal pressure (70% of the participant's usual pressure), and the second, was as per the first trial, but with the improved CPAP setup using pressure oscillations . The added pressure oscillations was 1 cmH2O. The apparatus used to do this trial will comprise a CPAP device as per the above set at 70% of your usual pressure with a pressure oscillator connected to the usual CPAP. Both techniques used without humidification.

The pressure oscillations were the same for all participants. A minimum break period was included between each trial, at least 24 hours between trials.

sleep lab attendance checklists were considered and each participant has a case report form that all the resulted data were reported in to compare the two therapies results for each participant.

The participant was sleep in sleep labs with a comfortable bed. and they asked to wear your usual CPAP full face mask and to lie down, relax and go to sleep as they usually would. Sensors is attached to their head and body to collect data about their sleep and CPAP therapy.

sleep data is saved, and then they have been asked to come back at an agreed time for the second sleep study of the same duration. no follow-ups appointments after this trials.

During nights, they've been monitored by a noninvasive device called Polysomnography or PSG.

The Polysomnography device model type that will be used in the trials is the Embla S4500, used to collect their physiological data during sleep, as well as identifying sleep arousals.

The Polysomnography collects data via multiple electrodes/sensors to their head and body.

The head electrodes record the following physiological parameters:

• Brain activity: Electroencephalograph (EEG).
• Chin muscle activity: Electromyography (EMG).
• Eye muscle movement: Electrooculography (EOG).
• Snoring recorder.

The body electrodes recorded the following physiological parameters:

• Heart rhythm via Electrocardiograph ECG.
• Oxygen level in the blood, by placing a sensor on the indicator fingertip.
• Breathing effort by wearing two belts, one on the chest and the other on the abdomen.
• Skeletal muscle activity (EMG). Where the electrodes are attached to the legs.



A function generator was connected to control the pressure oscillations, and the Polysomnography was used to gauge the status of the sleep. All sleeping parameters was recorded via the Polysomnography.

Saliva samples was taken before and after each trial to make a comparison in the mouth dryness when using CPAP and superimposed pressure oscillations with CPAP. This is conducted by comparing the quantity or the volume of saliva.

For the saliva collection, they instructed to rinse your mouth thoroughly with deionized water prior to collection. Then seated upright and relaxed accumulate saliva in the floor of the mouth and to then spit into a cylinder. This will take 5 minutes, once completed, samples are then discarded.
When the trials and tests are completed, their code information data is held in the Auckland University of Technology (AUT), Institute of Biomedical Technologies (IBTec). It is a controlled-access database, which means that the information in this database is available only to researchers of IBTec. The results analyzed to get the conclusion of the study.
Intervention code [1] 324538 0
Treatment: Devices
Comparator / control treatment
CPAP therapy

the first study night using CPAP as per standard practice but set to 70% of the participant's usual pressure and without added humidification (which is sometimes used as part of usual CPAP therapy).
Control group
Active

Outcomes
Primary outcome [1] 332763 0
The number of upper airway obstructions in supine position recorded by the Polysomnography.
Timepoint [1] 332763 0
Immediately while using the device
Primary outcome [2] 332764 0
The saliva volume were recorded without humidification
Timepoint [2] 332764 0
Immediately after using the device
Primary outcome [3] 333275 0
Sleeping comfort assessed using a 5-point Likert scale
Timepoint [3] 333275 0
immediately after using the device
Secondary outcome [1] 414653 0
The Respiratory arousal index recorded by the polysomnography
Timepoint [1] 414653 0
Immediately after using the device
Secondary outcome [2] 416426 0
oxygen desaturation index recorded by the polysomnography
Timepoint [2] 416426 0
immediately whole using the device
Secondary outcome [3] 416430 0
Apnoea-hypopnoea index in supine sleeping position recorded by the polysomnography
Timepoint [3] 416430 0
immediately after using the device
Secondary outcome [4] 416431 0
Rapid eye movement (REM) apnoea-hypopnoea index recorded by the polysomnography
Timepoint [4] 416431 0
immediately after using the device
Secondary outcome [5] 416432 0
Non-REM (NREM) apnoea-hypopnoea index recorded by the polysomnography'
Timepoint [5] 416432 0
immediately after using the device
Secondary outcome [6] 416433 0
Non-supine apnoea-hypopnoea index recorded by the polysomnography
Timepoint [6] 416433 0
immediately after using the device

Eligibility
Key inclusion criteria
1. Age is 18 years or older.
2. Participants with Apnea–Hypopnea Index (AHI) with more than 5 events per hour.
3. Participants who are using CPAP only.
4. Good tolerance to CPAP (More than 4 hours a night on average over the last 3 months).
5. Participants who are using full face mask.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with insomnia or other sleep disorders.
2. Participants who have had any surgical intervention as a treatment for obstructive sleep apnea.
3. Participants who have had metallic implants through their upper airways.
4. Participants with pacemakers.
5. Participants who are pregnant or think they may be pregnant.
6. Participants who are using APAP, BiPAP, or any other devices rather than CPAP.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Safety concerns
Date of first participant enrolment
Anticipated
Actual
6/09/2018
Date of last participant enrolment
Anticipated
Actual
13/03/2019
Date of last data collection
Anticipated
Actual
19/03/2019
Sample size
Target
60
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 25055 0
New Zealand
State/province [1] 25055 0
Auckland

Funding & Sponsors
Funding source category [1] 312335 0
Commercial sector/Industry
Name [1] 312335 0
Callaghan Innovation
Country [1] 312335 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 313897 0
None
Name [1] 313897 0
NA
Address [1] 313897 0
NA
Country [1] 313897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311703 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 311703 0
Ethics committee country [1] 311703 0
New Zealand
Date submitted for ethics approval [1] 311703 0
20/02/2018
Approval date [1] 311703 0
11/05/2018
Ethics approval number [1] 311703 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122058 0
Prof Ahmed Al-Jumaily
Address 122058 0
Auckland University of Technology, 55 Wellesley Street, East Auckland City, Auckland 1010
Country 122058 0
New Zealand
Phone 122058 0
+64 9 9219777
Fax 122058 0
Email 122058 0
[email protected]
Contact person for public queries
Name 122059 0
Ahmed Al-Jumaily
Address 122059 0
Auckland University of Technology, 55 Wellesley Street, East Auckland City, Auckland 1010
Country 122059 0
New Zealand
Phone 122059 0
+64 9 9219777
Fax 122059 0
Email 122059 0
[email protected]
Contact person for scientific queries
Name 122060 0
Ahmed Al-Jumaily
Address 122060 0
Auckland University of Technology, 55 Wellesley Street, East Auckland City, Auckland 1010
Country 122060 0
New Zealand
Phone 122060 0
+64 9 9219777
Fax 122060 0
Email 122060 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.