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

NCT ID: NCT06463002

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-09-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

OSA treated

Patients with OSA treated with CPAP for at least six months

Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

Intervention Type: DIAGNOSTIC_TEST

Noninvasive tests to assess blood pressure control and cognition

OSA untreated

Patients with OSA not treated with CPAP

Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

Intervention Type: DIAGNOSTIC_TEST

Noninvasive tests to assess blood pressure control and cognition

non-OSA

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

Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

Intervention Type: DIAGNOSTIC_TEST

Noninvasive tests to assess blood pressure control and cognition

Interventions

Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

Noninvasive tests to assess blood pressure control and cognition

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandra Hospital

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National University Hospital

Singapore, SG, Singapore

Countries

Singapore

Other Identifiers

2023/01017

Identifier Type: -

Identifier Source: org_study_id