None listed
Conditions
Brief summary
Over 80% of people living with spinal cord injury (SCI) have sleep apnoea. This study will investigate the feasibility of a novel physiotherapy-led outpatient model for identifying and managing sleep apnoea in SCI. People attending outpatient clinics of two state-wide SCI services (Victoria and Queensland) will be screened for risk of sleep apnoea. Those at risk will be referred to a highly trained neuro-respiratory physiotherapist, located within the health service and supported by a respiratory specialist, for ambulatory investigations and management. A thorough process evaluation will assess the feasibility of this alternative care model and estimate the impact on important clinical outcomes.
Interventions
The FASST-SCI care model: Patients of two statewide spinal cord injury (SCI) services (Victoria and Queensland) will be screened for risk of sleep apnoea by research or clinic staff prior to or at their routine outpatient appointment. Those at risk will be referred to a highly trained neuro-respiratory physiotherapist, located within the health service, for ambulatory investigations and management. “At-risk” is defined as people with SCI who: - are not currently treated for sleep disordered breathing (SDB) (with positive airway pressure therapy or mandibular advancement device) AND - have not been investigated for SDB with an overnight sleep study in the previous 3 years, unless this investigation identified SDB and the person is not on treatment. Research or clinic staff will discuss the FASST-SCI clinic with those identified as "at risk". If agreeable, the spinal doctor will refer the patient to the FASST-SCI clinic where the physiotherapist will perform or arrange the following investigations: - Symptoms and history - Resting oxygen saturation (SpO2), daytime, upright, awake - Handheld spirometry - A Level 3 home sleep study (Resmed ApneaLinkAir), conducted in the patient’s home. The home sleep study is a portable device to be worn for 1 night. The device measures oxygen saturation with an oximeter worn on the finger, nasal flow with nasal prongs, and respiratory effort with a band around the abdomen. The physiotherapist will meet with a respiratory physician to discuss the results and collectively determine risk of hypoventilation or other respiratory complications and whether referral to a respiratory physician for further investigations is needed. The following risk factors for sleep-related hypoventilation will be considered by the FASST-SCI physiotherapist and respiratory physician: Resting awake upright SpO2 < 93%; Presence of regular opiate medication; Presence of regular morning headaches; Body Mass Index > 35kg/m2; Forced Vital Capacity (FVC) <50% predicted and/or FVC<1.8L; SpO2 10% of total sleep time (T90%); Recurrent lower respiratory tract infections requiring antibiotic therapy in the community in the preceding 12 months; Documented left ventricle ejection fraction (LV EF) <35% on echocardiogram in the last 12 months. The physiotherapist will collate this information during their initial FASST-SCI appointment, and the results will be discussed with the respiratory physician to determine the risk of harm and whether referral to a respiratory physician for further investigation of hypoventilation is needed. If the person is deemed to be a risk of hypoventilation, they will be referred to a respiratory physician and exit the FASST-SCI clinic. For those who do not require further investigation for possible underlying hypoventilation, the physiotherapist (with respiratory physician support and endorsement) will establish if treatment-indicated sleep apnoea is present. Treatment indicated sleep apnoea is defined as: - Apnoea Hypopnoea Index (AHI) and/or 3% Oxygen Desaturation Index (ODI) = 20/hr from overnight sleep study OR - AHI and/ or 3%ODI =10 and <20/hr with symptoms (and considering patient preferences and suitability for treatment). Those who do not meet these criteria for diagnosis will be discharged from the FASST-SCI clinic and referred to their GP or a respiratory physician where appropriate. Participants diagnosed with sleep apnoea and recommended treatment will be referred to a community-based continuous positive airway pressure (CPAP) provider for treatment initiation. The referral will include the recommended parameters in which to commence CPAP (i.e. pressure, mode etc), as determined by the FASST-SCI physiotherapist, in collaboration with the respiratory physician. Approximately 1-2 weeks prior to their initial appointment with the CPAP provider, the patient will be offered a psycho-education session delivered by the FASST-SCI physiotherapist, to prepare them for treatment and maximise uptake and adherence, Following CPAP initiation, the physiotherapist will contact the participant in the first week and work with the CPAP provider and participant over the subsequent 3 months to troubleshoot any issues, assess the risk of hypoventilation, and progress treatment as needed. Review appointments will be face-to-face or via telehealth (video-conferencing or telephone). Review appointments will include assessment of morning headaches, changes in symptoms, daytime SpO2 (if face-to-face), and treatment usage and side effects. Another home sleep study may be conducted if clinically indicated. Adjustments to masks and pressures will be made as required. Review appointments will be conducted as needed; there is no minimum or maximum number. After 3 months the person will be discharged from the FASST-SCI clinic and referred to their GP or a respiratory specialist for ongoing care, as needed. Nested Mandibular Advancement Device (MAD) study (Victorian site only): Patients of the Victorian Spinal Cord Service, who are diagnosed with sleep apnoea and recommended treatment, will be offered the choice of treatment with CPAP or MAD. A maximum of 30 participants will be able to choose MAD, after which only CPAP will be available. Those who choose CPAP will be managed according to the protocol described above. Those who choose MAD will be referred to a specialist sleep dentist for a suitability assessment (including a full dental and oral examination). Prior to their dentist appointment, they will attend the online psycho-education session, delivered online by the FASST-SCI physiotherapist, as described earlier. The MAD will initially be set to 50% of maximum protrusion capacity. Level of protrusion is defined as the position between maximal retrusion and maximal protrusion. MADs will be fitted with a DentiTrac thermosensitive microsensor (Braebon Medical Corporation, Kanata, Canada) to assess objective adherence. The customised MAD will be delivered to the FASST-SCI physiotherapist for fitting, education, titration, and troubleshooting, with dentist support as required. Briefly, titration will involve advancing the mandible within the participants comfort levels, usually around 70-75% maximal protrusion. Titration will be guided by participant comfort. The number of times a participant is contacted will vary depending on time taken to achieve maximal protrusion. There is no set number of review appointments. However, adjustments will be made weekly depending upon participant comfort levels. Participants in this treatment pathway will undergo the same assessments for hypoventilation risk and treatment response as those using CPAP. They will receive the same treatment support, progression and ongoing care. After 3 months, they will be discharged from the FASST-SCI clinic to their GP, dentist, or respiratory physician, as clinically needed. The same referral pathways for those experiencing symptoms of hypoventilation and poor treatment response will apply.
Sponsors
Study design
Eligibility
Inclusion criteria
• Adults living with SCI in the community (tetraplegia and paraplegia; traumatic and non-traumatic causes) • Attending the outpatient clinics of the Victorian and Queensland Spinal Cord Services. • Not currently treated for sleep disordered breathing (i.e. positive airway pressure therapy or MAD) • Has NOT been investigated for sleep disordered breathing with an overnight sleep study in the last 3 years OR diagnosed with sleep disordered breathing in the last 3 years and NOT currently on treatment.
Exclusion criteria
• Investigated for sleep disordered breathing in the previous 3 years, with a report indicating no sleep disordered breathing. • Significant, inadequately managed, mental health issues / behaviours of concern. • Unable to provide informed consent.