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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Singapore
  • SG
    • Singapore, SG, Singapore, 119228
      • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals who fulfil the inclusion criteria but not the exclusion criteria will be recruited.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA treated; Patients with OSA treated with CPAP for at least six months	Diagnostic test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment; Noninvasive tests to assess blood pressure control and cognition
OSA untreated; Patients with OSA not treated with CPAP	Diagnostic test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment; Noninvasive tests to assess blood pressure control and cognition
non-OSA; Patients underwent a sleep study and were diagnosed not to have OSA	Diagnostic test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment; Noninvasive tests to assess blood pressure control and cognition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour mean systolic blood pressure	A 24-hour ambulatory blood pressure monitoring will be performed	Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA)	Montreal Cognitive Assessment scale (0-30). Lower the scale means more severe cognitive impairment	Within 4 weeks after consent (one time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office systolic blood pressure	Office blood pressure will be record	Within 4 weeks after consent (one time)
24-hour systolic blood pressure <130 mmHg	24-hour systolic blood pressure <130 mmHg based on the ambulatory BP monitoring	Within 4 weeks after consent (one time)
24-hour systolic blood pressure <120 mmHg	24-hour systolic blood pressure <120 mmHg based on the ambulatory BP monitoring	Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <27	Prevalence of participants with Montreal Cognitive Assessment (MoCA) <27	Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <20	Prevalence of participants with Montreal Cognitive Assessment (MoCA) <20	Within 4 weeks after consent (one time)
MoCA score <27 (for those with >10 years of education) and <26 (for those with ≤10 years of education)	Prevalence of participants with 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)
Epworth Sleepiness Scale	Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness	Within 4 weeks after consent (one time)
Nocturnal blood pressure dipping	Percentage of Participants with >10% drop in nocturnal systolic blood pressure based on the ambulatory BP monitoring	Within 4 weeks after consent (one time)

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: Alexandra Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Obstructive Sleep Apnea; Cognitive impairment
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2023/01017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to make individual participant data (IPD) available to other researchers at least 5 years after study completion, subjected to final approval by the PI
• IPD Sharing Time Frame: At least 5 years after study completion
• IPD Sharing Access Criteria: Plan to make individual participant data (IPD) available to other researchers at least 5 years after study completion, subjected to final approval by the PI
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No