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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06463002
Acronym
AMPLE
Enrollment
150
Registered
2024-06-17
Start date
2024-07-31
Completion date
2025-09-30
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Hypertension, Cognitive impairment

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.

Interventions

DIAGNOSTIC_TESTAmbulatory blood pressure monitoring and Montreal Cognitive Assessment

Noninvasive tests to assess blood pressure control and cognition

Sponsors

Alexandra Hospital
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
24-hour mean systolic blood pressureWithin 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

MeasureTime frameDescription
Nocturnal blood pressure dippingWithin 4 weeks after consent (one time)Percentage of Participants with \>10% drop in nocturnal systolic blood pressure based on the ambulatory BP monitoring
24-hour systolic blood pressure <130 mmHgWithin 4 weeks after consent (one time)24-hour systolic blood pressure \<130 mmHg based on the ambulatory BP monitoring
24-hour systolic blood pressure <120 mmHgWithin 4 weeks after consent (one time)24-hour systolic blood pressure \<120 mmHg based on the ambulatory BP monitoring
Office systolic blood pressureWithin 4 weeks after consent (one time)Office blood pressure will be record
Montreal Cognitive Assessment (MoCA) <20Within 4 weeks after consent (one time)Prevalence of participants with Montreal Cognitive Assessment (MoCA) \<20
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)
Montreal Cognitive Assessment (MoCA) <27Within 4 weeks after consent (one time)Prevalence of participants with Montreal Cognitive Assessment (MoCA) \<27
Epworth Sleepiness ScaleWithin 4 weeks after consent (one time)Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026