None listed
Conditions
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.
Interventions
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 140 older people with confirmed OSA. Participants wil
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 140 older people with confirmed OSA. Participants will be recruited from Adelaide Metropolitan geriatric clinics and the community. This represents a population group 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 seven 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.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: • Adults aged >= 60 years; • Must be at high risk of a fall which is defined as: i) a fall within the last 6 months or ii) a fear of falling or iii) >= 80 years of age • 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
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. • Not currently participating in a research study relating to sleep and falls.
Outcome results
None listed