Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000818932
Ethics application status
Approved
Date submitted
1/06/2020
Date registered
17/08/2020
Date last updated
17/08/2020
Date data sharing statement initially provided
17/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Upper Airway Muscle Training on Obstructive Sleep Apnoea (OSA) Severity and Upper Airway Physiology
Scientific title
The Effects of Upper Airway Muscle Training on Obstructive Sleep Apnoea (OSA) Severity and Upper Airway Physiology
Secondary ID [1] 301371 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 317615 0
Condition category
Condition code
Respiratory 315691 315691 0 0
Sleep apnoea
Physical Medicine / Rehabilitation 316002 316002 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks of targeted upper airway muscle training to improve obstructive sleep apnoea. The training will commence the day after the participants first PSG study.

Exercises will target the soft palate, tongue and sub-mental muscles. Training will involve the use of an Expiratory Muscle Strength Trainer (EMST) and an IOPI medical device.
Participants will instructed on the exercises on day one, week 1, during a face-face consultation. Participants will have bi-weekly sessions with a speech pathologist by video consultation.

Training will be completed daily (~30 mins) at home for 12 weeks. Participants will be asked to complete a daily training diary to monitor adherence to the training protocol. Training will involve (1) prolonged holds and (2) pulses on an air-filled tongue bulb. The number of repetitions will be tailored to participants' baseline performance. For example, during baseline testing, participants maximum repetitions and durations will be determined. Participants will perform the hold at 50% of max effort (as they get "stronger" this value will increase, but it will always remain at 50% max effort). The repetitions will increase by 5% bi-weekly. This will be done during bi-weekly consultations with the speech-pathologist.

Similarly, the EMST starting resistance will be tailored to participants' baseline peak expiratory flow. During baseline testing, participants max peak expiratory effort will be determined. Each week, the EMST will be increased by a quarter turn (as per EMST protocol). Participants will complete 5 sets of EMST comprising 5 repetitions per set. This will be completed 5 times per week (as per EMST protocol).
Intervention code [1] 317676 0
Treatment: Other
Intervention code [2] 317895 0
Treatment: Devices
Comparator / control treatment
Before-after study: Baselines assessment (week 1) results will be compared to performance at week 12.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323921 0
Apnoea-Hypopnea Index (AHI) - the severity of sleep apnea, i.e. the number of apnea and hypopnea events during sleep.

Timepoint [1] 323921 0
Measured before (week 1) and after (week 12) muscle training.
Secondary outcome [1] 383339 0
Tongue strength as measured with the IOPI device.

Timepoint [1] 383339 0
Week 1 and week 12
Secondary outcome [2] 384048 0
Upper airway collapsibility index (UACI) during wakefulness.
Two pressure tipped sensors will be placed into a decongested, anaesthetised nostril, one to the level of the choanae (back of the nose) and the other just below the base of the tongue (level of the epiglottis). Participants will be fitted with a nasal mask attached to a breathing tube. Brief (~ 250 ms) negative pressure pulses (~ -12 cmH2O at the mask) are applied intermittently every 2-10 breaths during early inspiration, via computer-controlled software that enables rapid shifting from room air to the negative pressure source. The test takes ~15 mins to complete.
Timepoint [2] 384048 0
Week 1 and week 12
Secondary outcome [3] 384049 0
Respiratory Load Magnitude sensory test.
Participants will be studied during wakefulness, in the supine position while wearing a nasal mask. The mask will be connected to carbon dioxide and mask pressure sensors. The pneumotachograph will be connected to a breathing tube, which will be connected to a stopcock with an additional airflow port, where the addition of inspiratory loads can be added without interruption to quiet breathing. Participants will be instructed to breathe through their nose for the duration of the test. Nasal decongestant will be given to both nostrils before the breathing test. Initially, examples of the lowest and highest loads will be presented. Following this, loads will be randomly presented for a breath, very 3-4 breaths for three times each. Immediately after each load, participants will be asked to rate their perceived difficulty breathing on a modified Borg scale, from 1-10. The test will last ~10 min.
Timepoint [3] 384049 0
Week 1 and week 12
Secondary outcome [4] 384050 0
Sleep Questionnaire: Epworth Sleepiness Scale
Timepoint [4] 384050 0
Pre and post treatment (week 1 and 12)
Secondary outcome [5] 385072 0
Sleep Questionnaires: Insomnia Severity Index
Timepoint [5] 385072 0
Pre and post treatment (week 1 and 12)
Secondary outcome [6] 385073 0
Tongue endurance as measured with the IOPI device.
Timepoint [6] 385073 0
Pre and post treatment (week 1 and 12)

Eligibility
Key inclusion criteria
Male or female
Otherwise healthy with a confirmed diagnosis of OSA.
AHI greater than 5 events/h on pre-training PSG night.
Currently not on treatment, or have previously failed treatment for OSA
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant craniofacial malformation.
Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control.
Clinically significant neurological disorder, including epilepsy/convulsions.
Clinically significant cognitive dysfunction
Participants who have had upper airway surgery < 1 year prior to participation

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)
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
Based on a sample size calculation, 16 participants will allow us to detect a >7.5 change in AHI (SD=10), with >80% power (2-tailed paired t-test, alpha=0.05).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305811 0
Charities/Societies/Foundations
Name [1] 305811 0
Australasian Sleep Association Phillips Grant
Country [1] 305811 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Adelaide Institute for Sleep Health
Flinders University , Mark Oliphant Building,
5 Laffer Drive
Bedford Park
SA 5049
Country
Australia
Secondary sponsor category [1] 306259 0
None
Name [1] 306259 0
Address [1] 306259 0
Country [1] 306259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306081 0
Southern Adelaide Local Health Network
Ethics committee address [1] 306081 0
Ethics committee country [1] 306081 0
Australia
Date submitted for ethics approval [1] 306081 0
Approval date [1] 306081 0
17/03/2020
Ethics approval number [1] 306081 0
HREC/19/SAC/318

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

Contacts
Principal investigator
Name 102634 0
Dr Jayne Carberry
Address 102634 0
AISH, Flinders University
Mark Oliphant Building
5 Laffer Drive,
Bedford Park
SA 5049
Country 102634 0
Australia
Phone 102634 0
+61882019156
Fax 102634 0
Email 102634 0
[email protected]
Contact person for public queries
Name 102635 0
Emma Wallace
Address 102635 0
AISH, Flinders University
Mark Oliphant Building
5 Laffer Drive,
Bedford Park
SA 5049
Country 102635 0
Australia
Phone 102635 0
+61882019177
Fax 102635 0
Email 102635 0
[email protected]
Contact person for scientific queries
Name 102636 0
Jayne Carberry
Address 102636 0
AISH, Flinders University
Mark Oliphant Building
5 Laffer Drive,
Bedford Park
SA 5049
Country 102636 0
Australia
Phone 102636 0
+61882019156
Fax 102636 0
Email 102636 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
N/A


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.