Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000965606
Ethics application status
Approved
Date submitted
25/07/2023
Date registered
6/09/2023
Date last updated
9/05/2024
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing fall risk by treating obstructive sleep apnea in older people
Scientific title
Efficacy of obstructive sleep apnea treatment in reducing fall risk in older people
Secondary ID [1] 309425 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 329679 0
Fall risk 329680 0
Condition category
Condition code
Respiratory 326577 326577 0 0
Sleep apnoea
Physical Medicine / Rehabilitation 326578 326578 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 327825 327825 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 3-year randomised control trial aims to examine whether older adults with moderate to severe obstructive sleep apnea (OSA) will have an improvement in fall risk markers and daytime gait quality after six months of treatment with continuous positive airway pressure (CPAP). This trial will also examine whether night-to-night variation in OSA impacts next day gait quality.

The trial will be conducted in a clinically high fall risk group of 120 older people with confirmed OSA. Participants will be recruited from Flinders Medical Centre Rehabilitation Outpatients Falls Clinics and the Aged & Extended Care Services (Geriatric Medicine), The Queen Elizabeth Hospital, Central Adelaide Local Health Network. This represents a patient group already at elevated fall risk and in whom OSA treatment has the potential to markedly reduce fall risk. All patients will be screened for moderate to severe OSA and will be randomised (1:1) to receiving an active intervention (management as usual + CPAP). Treatment for OSA will be via CPAP as recommended by a sleep specialist as per best clinical practice. A qualified CPAP nurse working closely with the clinical investigators will provide one-on-one CPAP education and trial a range of different masks (nasal mask, full face or nasal pillow mask) to find the one best suited to the participant to minimise any discomfort. The CPAP education session will cover topics on the need for CPAP, how CPAP works, use and maintenance of equipment, mask leak, potential side effects and skin irritation. Participants will be advised to use their CPAP device all night every night. This session is expected to take no more than 60 minutes. The fixed CPAP pressure will be determined by an automatic positive airway pressure device trialled over four nights. Courier services will be organised to aid in the pick-up of the device if the participant is not able to attend the clinic in-person. As per clinical practice the participant will be invited to attend the clinic to obtain their fixed pressure CPAP device. All ResMed devices used in the study are capable of logging adherence data to the online ResMed portal via WIFI and will aid in the monitoring of CPAP adherence. As per standard clinical practice the CPAP nurse will follow-up after two weeks of CPAP commencement via telephone and again one month later to ensure the participant is not experiencing issues and to assess adherence. Participants will be encouraged to attend earlier and/or more frequent review appointments with the nurse if they experience difficulties with CPAP use. Participants will not be excluded from the trial based on their CPAP usage. Adherence to CPAP will be documented at three- and 6-month follow-up post CPAP commencement.
Intervention code [1] 325852 0
Treatment: Devices
Comparator / control treatment
The control group will receive management as usual including standard falls rehabilitation care. This is individualised according to the risks for each of the patients. A standardised way of reporting this is a referral to physical rehabilitation and exercise to improve balance and strength, eyesight and hearing assessment and corrections, polypharmacy management (deprescribing), dietitian review and plan, if necessary, cognitive assessment and management, depression screening and management, incontinence assessment and treatment, Occupational therapy home assessment and home adaptations to increase safety if necessary. The control group will be evaluated for CPAP therapy after completion of the trial. The trial will include a maximum of 6 months follow-up to ensure patients in the treatment as usual arm receive appropriate OSA treatment within the current clinical practice timeframe (6-9 months).
Control group
Active

Outcomes
Primary outcome [1] 334430 0
Physiological Profile Assessment Fall Risk Score
Timepoint [1] 334430 0
The primary outcome will be assessed at baseline, 3 months and 6 months after commencement of intervention. The primary time point will be 6 months post-commencement of intervention.
Secondary outcome [1] 420605 0
The secondary outcome of interest is gait quality in home-setting. This will be measured at home using the McRoberts MoveMonitor inertial sensor for one week at three timepoints (baseline, 3-month follow-up and 6-month follow-up post intervention.



Timepoint [1] 420605 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [2] 425586 0
Psychomotor speed, set shifting and working memory will be assessed using the Trail Making A & B test.

Timepoint [2] 425586 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [3] 425587 0
Grip Strength
Hand grip strength will be measured using a dynamometer.
Timepoint [3] 425587 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [4] 425588 0

Self-reported sleep quality will be examined using the validated Pittsburgh Sleep Quality
Timepoint [4] 425588 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [5] 425589 0
Self-reported anxiety symptoms
This will be determined from a validated questionnaire, Generalised Anxiety Disorder and GAD-7 (GAD-7).
Timepoint [5] 425589 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [6] 425590 0
Self-reported depression symptoms

This will be determined from a validated questionnaire, Patient Health Questionnaire-9 (PHQ-9)
Timepoint [6] 425590 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [7] 425593 0
Quality of life

This will be determined from a validated questionnaire, EQ-5D-5L.
Timepoint [7] 425593 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [8] 425594 0
Self-reported muscle strength will be determined from a validated questionnaire, Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire. The SARC-F questionnaire assesses all components to provide a compositive self-reported muscle strength symptom score.
Timepoint [8] 425594 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [9] 425595 0
Home-based sleep quality

A non-invasive validated under mattress sensor (Whitings sleep Analyzer) will be used for a one-week period at each time-point to assess night-night sleep quality in the home setting. This will be accompanied by a self-reported sleep diary of sleep and wake times.
Timepoint [9] 425595 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [10] 425596 0
Physical Activity
A Fitbit physical activity monitor will be used to examine physical activity for a one-week period in the home setting at each timepoint. This monitor is also capable of deriving sleep and wake times based on physical activity and will thus aid in the home sleep quality assessment.
Timepoint [10] 425596 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [11] 426353 0
The Victoria Stroop colour test will assess conflict resolution and inhibition.
Timepoint [11] 426353 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [12] 426354 0
Insomnia symptoms will be assessed using the validated Insomnia Severity Index (ISI).
Timepoint [12] 426354 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.
Secondary outcome [13] 426355 0
Symptoms of restless legs syndrome will be assessed using the International Restless Legs Syndrome Study Group diagnostic criteria.
Timepoint [13] 426355 0
Outcome will be assessed at baseline, 3- and 6 months post-intervention.

Eligibility
Key inclusion criteria
Inclusion criteria:

• Adults aged >= 65 years;
• able to walk 20 metres without rest;
• OSA50 questionnaire score >5
• Epworth Sleepiness Scale score =15 or >15 if not currently driving.
• Polysomnography (PSG) and physician confirmed OSA (apnoea hypopnoea index (AHI) >=15/h).
• All participants must not have used CPAP or mandibular advancement splint for at least the last 6 months and be able to perform physiological, fall risk and cognitive assessments.
• Insomnia Severity Index Score <15
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• already treated for OSA,
• experience regular syncope/dizziness/vertigo,
• have suffered an injury that may affect falls risk (such as non-fall related lower limb fracture, lower limb muscular injury),
• Severe or unstable medical conditions (e.g., acute cardiac or respiratory failure, chronic obstructive pulmonary disease, history of traumatic brain injury, stroke with
neurological sequelae or neurodegenerative disorder [e.g., Parkinson’s, dementia])
• Cognitive impairment (Montreal Cognitive assessment score <=18)
• uncontrolled severe depression/anxiety.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the intervention group relative to the treatment as usual group will be determined using a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation for the present study was calculated to detect a clinically meaningful post-intervention between group difference of 0.5 for the fall risk score on the PPA. While there are no prior randomised control trial studies examining the mean difference in PPA fall risk scores among individuals with OSA after a CPAP intervention, we anticipate the post-intervention score will be of a similar magnitude to previous exercise intervention trials.38 Therefore, 56 participants were required for each arm using a SD of mean differences of 0.93, power of 80% and type one error of 5%. To account for 20% attrition the adjusted sample size was 70 for each group, or 140 in total.
Data will be analysed on an intention-to-treat basis by a statistician blinded to treatment allocation. For the primary outcome at six months, we will use a linear mixed model with arm as the main predictor and baseline PPA, plus age and sex as potential covariates and study site as a random effect (using restricted maximum likelihood estimation). For the secondary outcome assessing variability of night-to-night sleep metrics (sleep duration, sleep efficiency, AHI) on next day gait quality we will use the standard deviation and range (maximum and minimum) of the metrics for each participant and model this against baseline fall risk measures (PPA fall risk score and gait speed and quality from home assessment) using generalised linear models and adjusted for age and sex. For other secondary outcomes will use generalised linear mixed models with the baseline measure added as a covariate and age and sex as potential confounders. The model will have random intercepts of participants nested in study site.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/09/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25124 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 25125 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 40792 0
5011 - Woodville
Recruitment postcode(s) [2] 40791 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 313619 0
Commercial sector/Industry
Name [1] 313619 0
The ResMed Foundation
Country [1] 313619 0
United States of America
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 316279 0
None
Name [1] 316279 0
Address [1] 316279 0
Country [1] 316279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312792 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312792 0
Flinders Medical Centre, Bedford Park SA 5042 (WARD 6C Room 6A219)
Ethics committee country [1] 312792 0
Australia
Date submitted for ethics approval [1] 312792 0
03/04/2023
Approval date [1] 312792 0
10/07/2023
Ethics approval number [1] 312792 0
2023/HRE00081

Summary
Brief summary
Falls are a major cause of preventable injury, hospitalisation, morbidity, and mortality in older adults. 1 in 3 people aged 65 years or greater living at home experience a fall annually. Emerging evidence indicates obstructive sleep apnea (OSA), a common sleep breathing disorder (~50%) in older people, may be an independent contributor to fall risk. Balance and gait decline with time awake and can vary across the circadian cycle with specific periods of vulnerability (e.g., transition in posture, standing up and toileting). In addition, the severity of OSA varies significantly from night to night, which may exacerbate gait abnormalities and fall risk in older people. There is currently a lack of robust evidence that OSA treatment reduces fall risk, hence, OSA is currently ignored in falls prevention and reduction strategies. To address this knowledge gap, our internationally recognised team of clinicians and researcher experts in sleep health, fall risk prevention and rehabilitation will build on our successful uncontrolled pilot study and propose to conduct a randomised controlled trial (RCT) to : (1) establish if treatment of OSA with 6 months of CPAP reduces fall risk markers and improves daytime gait quality, (2) provide first in field insight into the temporal relationship between night-to-night variation in OSA with next day gait quality to identify periods of potential increased vulnerability to falls. We hypothesise that 6 months of CPAP treatment will reduce fall risk markers and improve walking and balance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125938 0
A/Prof Andrew Vakulin
Address 125938 0
Mark Oliphant BuildingFlinders University 5 Laffer Dr, Bedford Park SA 5042
Country 125938 0
Australia
Phone 125938 0
+61 08 7221 8308
Fax 125938 0
Email 125938 0
andrew.vakulin@flinders.edu.au
Contact person for public queries
Name 125939 0
A/Prof Andrew Vakulin
Address 125939 0
Mark Oliphant BuildingFlinders University 5 Laffer Dr, Bedford Park SA 5042
Country 125939 0
Australia
Phone 125939 0
+61 08 7221 8308
Fax 125939 0
Email 125939 0
andrew.vakulin@flinders.edu.au
Contact person for scientific queries
Name 125940 0
A/Prof Andrew Vakulin
Address 125940 0
Mark Oliphant BuildingFlinders University 5 Laffer Dr, Bedford Park SA 5042
Country 125940 0
Australia
Phone 125940 0
+61 08 7221 8308
Fax 125940 0
Email 125940 0
andrew.vakulin@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published data will be shared upon request.
When will data be available (start and end dates)?
Immediately following publication and no anticipated end date
Available to whom?
The data will be shared on a case-by-case basis at the discretion of the principal investigator.
Available for what types of analyses?
Data analyses will be approved to achieve aims outlined in a research proposal or for meta-analyses.
How or where can data be obtained?
Access will be subject to approval by the principal investigator who can be contacted by emailing "andrew.vakulin@flinders.edu.au".


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.