Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)

National University Health System (NUHS)

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06463002

2023/01017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

150 participants in 3 patient groups

OSA treated

Description:

Patients with OSA treated with CPAP for at least six months

Treatment:

Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

OSA untreated

Description:

Patients with OSA not treated with CPAP

Treatment:

Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

non-OSA

Description:

Patients underwent a sleep study and were diagnosed not to have OSA

Treatment:

Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment