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

Obstructive Sleep Apnea Clinical Trial

— AMPLE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463002
• Other study ID #: 2023/01017
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Ambulatory blood pressure monitoring and Montreal Cognitive Assessment
Noninvasive tests to assess blood pressure control and cognition

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore	SG

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Alexandra Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour mean systolic blood pressure	A 24-hour ambulatory blood pressure monitoring will be performed	Within 4 weeks after consent (one time)
Primary	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	Office systolic blood pressure	Office blood pressure will be record	Within 4 weeks after consent (one time)
Secondary	Epworth Sleepiness Scale	Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness	Within 4 weeks after consent (one time)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Montreal Cognitive Assessment (MoCA) <27	Prevalence of participants with Montreal Cognitive Assessment (MoCA) <27	Within 4 weeks after consent (one time)
Secondary	Montreal Cognitive Assessment (MoCA) <20	Prevalence of participants with Montreal Cognitive Assessment (MoCA) <20	Within 4 weeks after consent (one time)
Secondary	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)