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

June 17, 2024 updated by: National University Hospital, Singapore

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour mean systolic blood pressure
Time Frame: Within 4 weeks after consent (one time)
A 24-hour ambulatory blood pressure monitoring will be performed
Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA)
Time Frame: Within 4 weeks after consent (one time)
Montreal Cognitive Assessment scale (0-30). Lower the scale means more severe cognitive impairment
Within 4 weeks after consent (one time)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Office systolic blood pressure
Time Frame: Within 4 weeks after consent (one time)
Office blood pressure will be record
Within 4 weeks after consent (one time)
24-hour systolic blood pressure <130 mmHg
Time Frame: Within 4 weeks after consent (one time)
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
Time Frame: Within 4 weeks after consent (one time)
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
Time Frame: Within 4 weeks after consent (one time)
Prevalence of participants with Montreal Cognitive Assessment (MoCA) <27
Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <20
Time Frame: Within 4 weeks after consent (one time)
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)
Time Frame: 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)
Within 4 weeks after consent (one time)
Epworth Sleepiness Scale
Time Frame: Within 4 weeks after consent (one time)
Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness
Within 4 weeks after consent (one time)
Nocturnal blood pressure dipping
Time Frame: Within 4 weeks after consent (one time)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alexandra Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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