Actively Recruiting
Cognition Recovery in Sleep Apnea Patients With Cardiovascular Risk by Evaluating Nasal CPAP Versus Dental Oral Appliance
Led by National University Hospital, Singapore · Updated on 2026-01-21
260
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
N
National University of Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA) is a common condition that causes breathing problems during sleep due to a blocked airway. It affects many adults worldwide and can lead to poor sleep, low oxygen levels, and increased health risks. People with OSA are more likely to develop cognitive problems, and the condition also results in a large economic burden. This trial aims to compare two treatments, continuous positive airway pressure (CPAP) and mandibular advancement devices (MAD), to see how they affect cognitive function and other health outcomes in adults with OSA and cardiovascular risks, focusing on Asian populations. Participants diagnosed with moderate-to-severe OSA and mild cognitive impairment will be randomly assigned to receive either CPAP or MAD treatment in equal groups. CPAP uses a machine to keep the airway open by providing constant air pressure during sleep, while MAD is a custom oral device that moves the lower jaw forward to prevent airway blockage. The study will include baseline assessments and follow-ups at six and twelve months, measuring cognitive function with the Montreal Cognitive Assessment (MoCA) and monitoring treatment adherence. During the trial, participants will undergo tests including brain MRI scans to explore brain structure and function, ambulatory blood pressure monitoring, sleep quality questionnaires, and assessments of sleep apnea severity. Researchers will track changes in cognitive function, device adherence, sleepiness levels, and biomarkers over time. The study will help understand how each treatment impacts cognitive recovery and other health measures over one year, with ongoing safety and outcome monitoring throughout the study period.
CONDITIONS
Brief Title
CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of at least 45 years
- Chinese, Malay, or Indian ethnicity
- Diagnosed with moderate-to-severe obstructive sleep apnea (AHI 215 events/hour)
- Mild cognitive impairment (MoCA score <27 for >10 years education, <26 for 210 years education)
- Agree to follow the study protocol
You will not qualify if you...
- Known obstructive sleep apnea already on regular treatment
- Severe cognitive impairment (MoCA <10)
- Severe hypoxemia on polysomnography (ODI >60 or minimum SpO2 <60%)
- History of schizophrenia, bipolar disorder, severe depression, drug abuse, or alcohol abuse
- Contraindications to MAD such as less than six teeth in each arch or inability to advance/open jaw
- Pre-existing temporomandibular joint problems, severe bruxism, advanced periodontal disease
- Life expectancy less than one year
- Cardiac or cerebrovascular events leading to hospitalization in past three months
- Complex cardiovascular diseases including cyanotic congenital heart disease or moderate to severe pulmonary hypertension
- Use of medications that affect neurocognitive function or alertness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants are fitted with and use either a Mandibular Advancement Device (MAD) or a Continuous Positive Airway Pressure (CPAP) machine to treat obstructive sleep apnea.
Baseline visit and follow-up visits at 6 months and 12 months
Duration - 12 months
Participants are monitored for cognitive function and device adherence after the intervention period.
Assessments at 6 months and 12 months post-baseline
Trial Site Locations
Total: 1 location
1
National University Hospital
Kent Ridge, Please Select, Singapore, 267383
Actively Recruiting
Research Team
C
Chi-Hang Lee, MBBS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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