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

NCT06463002 | Not Yet Recruiting

• 1 other identifier: 2023/01017
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Hypertension; Cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Office systolic blood pressure

  Within 4 weeks after consent (one time)

• Epworth Sleepiness Scale

  Within 4 weeks after consent (one time)

• Nocturnal blood pressure dipping

  Within 4 weeks after consent (one time)

• 24-hour systolic blood pressure <130 mmHg

  Within 4 weeks after consent (one time)

• 24-hour systolic blood pressure <120 mmHg

  Within 4 weeks after consent (one time)

Study Arms (3)

OSA treated

Patients with OSA treated with CPAP for at least six months

Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

OSA untreated

Patients with OSA not treated with CPAP

Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

non-OSA

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

Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment

Interventions

Ambulatory blood pressure monitoring and Montreal Cognitive Assessment DIAGNOSTIC_TEST

Noninvasive tests to assess blood pressure control and cognition

OSA treated; OSA untreated; non-OSA

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Alexandra Hospital: collaborator

Study Sites (1)

National University Hospital

Singapore, SG, 119228, Singapore

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Cognitive Dysfunction

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: At least 5 years after study completion
• 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

Locations

SG (1)