Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
Not provided
Not provided
Not provided
Not provided
Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI/AD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI/AD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI/AD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography. |
|
| Home Sleep Apnea Test | Experimental | Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-laboratory polysomnography | Device | Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who complete sleep testing | Proportion of patients who complete sleep testing by 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients diagnosed with OSA and treated using CPAP | Proportion of patients diagnosed with OSA and treated using CPAP by 6 months | 6 months |
| Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark I Boulos, MD, MSc | Contact | 4164804473 | mark.boulos@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark I Boulos, MD, MSc | University of Toronto and Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N3M5 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Home Sleep Apnea Test | Device | Use of a home sleep apnea test that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea. |
|
|
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
| 6 months |
| Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) | Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months | 6 months |
| Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) | Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months | 6 months |
| Mood (as assessed by the Geriatric Depression Scale) | Mood (as assessed by the Geriatric Depression Scale) at 6 months | 6 months |
| Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) | Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months | 6 months |
| Health Related Quality of Life (as assessed by the EQ-5D-5L) | Health Related Quality of Life (as assessed by the EQ-5D-5L) at 6 months | 6 months |
| Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) | Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months | 6 months |
| Cost to deliver each management strategy and treatment | Cost to deliver each management strategy and treatment by 6 months | 6 months |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000544 | Alzheimer Disease |
| D015140 | Dementia, Vascular |
| D060825 | Cognitive Dysfunction |
| D020961 | Lewy Body Disease |
| D000093902 | Mixed Dementias |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
Not provided
Not provided