Actively Recruiting
CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
Led by National University Hospital, Singapore · Updated on 2026-01-21
260
Participants Needed
1
Research Sites
260 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 prevalent condition that significantly impacts the sleep health and overall well-being of millions of adults worldwide. It is characterized by breathing difficulties during sleep caused by an obstructed upper airway, leading to fragmented sleep, oxygen deprivation, and increased sympathetic activity. OSA and its associated health problems contribute to an annual economic burden exceeding $150 billion in the United States. Studies have shown that individuals with OSA are 26% more likely to develop cognitive impairment compared to those without the condition. However, despite the effectiveness of continuous positive airway pressure (CPAP) therapy, many patients struggle with acceptance and adherence to this treatment. As an alternative, mandibular advancement devices (MADs) have gained acceptance among OSA patients by improving upper airway anatomy through repositioning of the jaw and tongue, thus reducing collapsibility. This non-invasive approach shows promise, particularly in addressing the unique craniofacial features commonly found in East Asian OSA patients. To further investigate the efficacy of MAD versus CPAP therapy, a multi-center, randomized clinical trial is proposed. The trial aims to evaluate cognitive function using established assessment tools and explore the relationship between different Asian ethnicities and changes in cognitive function, ambulatory blood pressure, and cerebral oxygen saturation. Additionally, brain MRI will be utilized to examine whether baseline brain structure and function can predict treatment response in OSA patients. Participants diagnosed with moderate-to-severe OSA will be randomly assigned to either the MAD or CPAP group in a 1:1 ratio. Baseline assessments, along with six-month and one-year follow-ups, will be conducted to assess the impact of the interventions. This trial seeks to provide valuable insights into the effectiveness of MAD versus CPAP therapy in Asian populations, specifically focusing on their effects on cognitive function and other relevant outcomes in individuals with OSA.
CONDITIONS
Official 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
- Suspected OSA and referred to participating sleep clinics
- Diagnosed with moderate-to-severe OSA (Apnea-Hypopnea Index ≥ 15 events/hour) by level 1 polysomnography
- Mild cognitive impairment defined by MoCA score <27 (for >10 years education) or <26 (for ≤10 years education)
- Agree to follow the study protocol
You will not qualify if you...
- Already diagnosed with OSA and on regular treatment
- Severe cognitive impairment (MoCA <10)
- Severe hypoxemia during polysomnography (Oxygen Desaturation Index >60 or minimum SpO2 <60%)
- Known schizophrenia, bipolar disorder, severe depression, drug abuse, or alcohol abuse
- Contraindications to MAD such as fewer than six teeth per arch, inability to advance mandible or open jaw widely
- Pre-existing temporomandibular joint problems, severe bruxism, or advanced periodontal disease
- Limited life expectancy (less than one year)
- Cardiac or cerebrovascular events requiring hospitalization within past three months
- Complex cardiovascular diseases including cyanotic congenital heart disease or moderate to severe pulmonary hypertension
- Using medications that affect neurocognitive function or alertness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here