Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment
- Registration Number
- NCT06463002
- Lead Sponsor
- National University Hospital, Singapore
- Brief Summary
To compare the blood pressure control and cognitive responses of three groups of patients: those diagnosed with Obstructive Sleep Apnea (OSA) and treated with Continuous Positive Airway Pressure (CPAP) for at least six months, those diagnosed with OSA but not treated, and those without OSA.
- Detailed Description
This study is designed as an observational, cross-sectional investigation at the National University Hospital and Alexandra Hospital. The research aims to enroll 50 eligible patients in each of the three groups (OSA treated, OSA untreated, and non-OSA, totaling 150 participants). The recruited participants will undergo ambulatory blood pressure monitoring (ABPM) and the Montreal Cognitive Assessment (MoCA). ABPM is a widely used, noninvasive method to determine patients' blood pressure control. MoCA is a widely used screening tool designed to assess cognitive function and detect mild cognitive impairment or early signs of dementia. The MoCA evaluates various cognitive domains, including attention, memory, language, visuospatial abilities, executive functions, and orientation. It consists of a series of tasks and questions that assess different aspects of cognitive functioning, such as drawing specific shapes, recalling words or numbers, and performing simple calculations. A trained healthcare professional will administer the digital version of the MoCA, which usually takes less than 30 minutes to complete. The MoCA has been validated for use in diverse populations and has shown good sensitivity in detecting mild cognitive impairment. The maximum score on the MoCA is 30. Lower scores may indicate potential cognitive impairment.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Known OSA (AHI >/=15 events/ hour, based on sleep study) on CPAP treatment for at least six months (n=50)
- Known OSA (AHI >/=15 events/ hour, based on sleep study) NOT on CPAP treatment (n=50)
- Known non-OSA (AHI <15 events/ hour, based on sleep study) (n=50)
- Known-OSA on non-CPAP treatment (e.g., mandibular advancement device, surgery, or hypoglossal nerve stimulation),
- Heart failure,
- Atrial fibrillation, or acute coronary syndrome in the prior 3 months
- Dementia (based on the medical record)
- Previous stroke
- Non-English-speaking subjects
- Pregnant and lactating women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description non-OSA Ambulatory blood pressure monitoring and Montreal Cognitive Assessment Patients underwent a sleep study and were diagnosed not to have OSA OSA treated Ambulatory blood pressure monitoring and Montreal Cognitive Assessment Patients with OSA treated with CPAP for at least six months OSA untreated Ambulatory blood pressure monitoring and Montreal Cognitive Assessment Patients with OSA not treated with CPAP
- Primary Outcome Measures
Name Time Method 24-hour mean systolic blood pressure Within 4 weeks after consent (one time) A 24-hour ambulatory blood pressure monitoring will be performed
Montreal Cognitive Assessment (MoCA) Within 4 weeks after consent (one time) Montreal Cognitive Assessment scale (0-30). Lower the scale means more severe cognitive impairment
- Secondary Outcome Measures
Name Time Method Office systolic blood pressure Within 4 weeks after consent (one time) Office blood pressure will be record
MoCA score <27 (for those with >10 years of education) and <26 (for those with ≤10 years of education) Within 4 weeks after consent (one time) Prevalence of participants with MoCA score \<27 (for those with \>10 years of education) and \<26 (for those with ≤10 years of education)
24-hour systolic blood pressure <120 mmHg Within 4 weeks after consent (one time) 24-hour systolic blood pressure \<120 mmHg based on the ambulatory BP monitoring
Epworth Sleepiness Scale Within 4 weeks after consent (one time) Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness
Nocturnal blood pressure dipping Within 4 weeks after consent (one time) Percentage of Participants with \>10% drop in nocturnal systolic blood pressure based on the ambulatory BP monitoring
Montreal Cognitive Assessment (MoCA) <27 Within 4 weeks after consent (one time) Prevalence of participants with Montreal Cognitive Assessment (MoCA) \<27
Montreal Cognitive Assessment (MoCA) <20 Within 4 weeks after consent (one time) Prevalence of participants with Montreal Cognitive Assessment (MoCA) \<20
24-hour systolic blood pressure <130 mmHg Within 4 weeks after consent (one time) 24-hour systolic blood pressure \<130 mmHg based on the ambulatory BP monitoring
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, SG, Singapore