Clinical trial NCT06463002: Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)
Official title: Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Hypertension
Cognitive impairment
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Alexandra Hospital
First posted: 2024-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who fulfil the inclusion criteria but not the exclusion criteria will be recruited.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24-hour mean systolic blood pressure
timeFrame: Within 4 weeks after consent (one time)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Within 4 weeks after consent (one time)
Secondary outcomes:
measure: Office systolic blood pressure
timeFrame: Within 4 weeks after consent (one time)
measure: Epworth Sleepiness Scale
timeFrame: Within 4 weeks after consent (one time)
measure: Nocturnal blood pressure dipping
timeFrame: Within 4 weeks after consent (one time)
measure: 24-hour systolic blood pressure <130 mmHg
timeFrame: Within 4 weeks after consent (one time)
measure: 24-hour systolic blood pressure <120 mmHg
timeFrame: Within 4 weeks after consent (one time)
measure: Montreal Cognitive Assessment (MoCA) <27
timeFrame: Within 4 weeks after consent (one time)
measure: Montreal Cognitive Assessment (MoCA) <20
timeFrame: Within 4 weeks after consent (one time)
measure: MoCA score <27 (for those with >10 years of education) and <26 (for those with ≤10 years of education)
timeFrame: Within 4 weeks after consent (one time)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
state: SG
Study officials:
References: