Obstructive Sleep ApneaAMPLENCT06463002
Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)
An observational study of Obstructive Sleep Apnea, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Ambulatory blood pressure monitoring and Montreal Cognitive Assessment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2024to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who fulfil the inclusion criteria but not the exclusion criteria will be recruited.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Ambulatory blood pressure monitoring and Montreal Cognitive Assessment
- Keywords
- Obstructive Sleep Apnea, Hypertension, Cognitive impairment
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure monitoring and Montreal Cognitive AssessmentDiagnostic test
Noninvasive tests to assess blood pressure control and cognition
| Study group | Role | What they receive |
|---|---|---|
| OSA treated | Patients with OSA treated with CPAP for at least six months Receives: Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment | |
| OSA untreated | Patients with OSA not treated with CPAP Receives: Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment | |
| non-OSA | Patients underwent a sleep study and were diagnosed not to have OSA Receives: Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour mean systolic blood pressure
A 24-hour ambulatory blood pressure monitoring will be performed
Measured: 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
Measured: Within 4 weeks after consent (one time)
Secondary outcomes (8)
Office systolic blood pressure
Office blood pressure will be record
Measured: Within 4 weeks after consent (one time)
Epworth Sleepiness Scale
Epworth Sleepiness Scale (4-24). Higher scale means more severe daytime sleepiness
Measured: Within 4 weeks after consent (one time)
Nocturnal blood pressure dipping
Percentage of Participants with >10% drop in nocturnal systolic blood pressure based on the ambulatory BP monitoring
Measured: Within 4 weeks after consent (one time)
24-hour systolic blood pressure <130 mmHg
24-hour systolic blood pressure <130 mmHg based on the ambulatory BP monitoring
Measured: Within 4 weeks after consent (one time)
24-hour systolic blood pressure <120 mmHg
24-hour systolic blood pressure <120 mmHg based on the ambulatory BP monitoring
Measured: Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <27
Prevalence of participants with Montreal Cognitive Assessment (MoCA) <27
Measured: Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <20
Prevalence of participants with Montreal Cognitive Assessment (MoCA) <20
Measured: 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)
Prevalence of participants with MoCA score <27 (for those with >10 years of education) and <26 (for those with ≤10 years of education)
Measured: Within 4 weeks after consent (one time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463002
- Sponsor's protocol ID
- 2023/01017
- Other IDs
- 2023
- Acronym
- AMPLE
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06463002
- Acronym / sponsor ID
- AMPLE / 2023/01017
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Hypertension, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Alexandra Hospital
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSA treated | – | Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive AssessmentPatients with OSA treated with CPAP for at least six months |
| OSA untreated | – | Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive AssessmentPatients with OSA not treated with CPAP |
| non-OSA | – | Diagnostic Test: Ambulatory blood pressure monitoring and Montreal Cognitive AssessmentPatients underwent a sleep study and were diagnosed not to have OSA |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who fulfil the inclusion criteria but not the exclusion criteria will be recruited.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory blood pressure monitoring and Montreal Cognitive AssessmentNoninvasive tests to assess blood pressure control and cognition | Diagnostic test | OSA treated, OSA untreated, non-OSA |
Primary outcome
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
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
8 secondary outcomes
Office systolic blood pressure
Time frame: Within 4 weeks after consent (one time)
Epworth Sleepiness Scale
Time frame: Within 4 weeks after consent (one time)
Nocturnal blood pressure dipping
Time frame: 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 <120 mmHg
Time frame: Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <27
Time frame: Within 4 weeks after consent (one time)
Montreal Cognitive Assessment (MoCA) <20
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: Yes. 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
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour mean systolic blood pressure (time frame: Within 4 weeks after consent (one time)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.