CPAP versus mandibular advancement mouthpiece for sleep apnea in people with mild cognitive impairment
Cognition Recovery in Sleep Apnea Patients With Cardiovascular Risk by Evaluating Nasal CPAP Versus Dental Oral Appliance
This project will try to see if a mandibular advancement device (a dental mouthpiece) works as well as nightly CPAP to improve thinking and memory in people over 45 with moderate-to-severe obstructive sleep apnea and mild cognitive impairment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Kent Ridge, Please Select) |
| Trial ID | NCT06983769 on ClinicalTrials.gov |
What this trial studies
Adults with moderate-to-severe OSA and mild cognitive impairment are randomly assigned 1:1 to nightly CPAP or a mandibular advancement device (MAD) and followed for 12 months. Cognitive function is measured at baseline, six months, and 12 months using the Montreal Cognitive Assessment (MoCA) as the primary outcome, with between-group differences analyzed by ANCOVA. The trial also collects detailed brain imaging (macrostructural and microstructural MRI, perfusion, diffusion-derived freewater, task-free fMRI, and diffusion-prepared perfusion) to test whether baseline brain measures predict cognitive recovery after treatment. The main hypothesis is that MAD will be non-inferior to CPAP for improving cognition in this population.
Who should consider this trial
Good fit: Adults aged 45 and older (Chinese, Malay, Indian) referred to participating Singapore sleep clinics with moderate-to-severe OSA (AHI ≥15), mild cognitive impairment by MoCA thresholds, cardiovascular risk, and not already on regular OSA treatment are ideal candidates.
Not a fit: People with severe cognitive impairment, extreme nocturnal hypoxemia, existing regular OSA treatment, major psychiatric/substance disorders, contraindications to MAD (e.g., insufficient teeth, TMJ disease), or limited life expectancy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could offer patients who struggle with CPAP a simpler oral device option that still preserves or improves thinking and memory.
How similar studies have performed: CPAP has documented benefits for sleep and some cognitive measures and MADs reduce OSA severity for many patients, but head-to-head trials focused on cognitive outcomes in people with mild cognitive impairment are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age of at least 45 Chinese, Malay, Indian Referred to the sleep clinics of the CRESCENDO participating centers for suspected OSA, underwent a clinically indicated level 1 polysomnography, and diagnosed to have moderate-to-severe OSA (AHI ≥ 15 events/hour) Mild cognitive impairment: MoCA score \<27 (for those with \>10 years of education) and \<26 (for those with ≤10 years of education) Agree to follow the study protocol Exclusion Criteria: Known OSA and already on regular treatment Severe cognitive impairment (MoCA \<10) Severe hypoxemia on polysomnography ODI \>60 or min SpO2 \<60% Known schizophrenia, bipolar disorder, severe depression, drug abuse or alcohol abuse Contraindications to MAD: less than six teeth in each arch; inability to advance the mandible and open the jaw widely. Pre-existing temporomandibular joint problems, severe bruxism, and advanced periodontal disease Limited life expectancy (\< one year) Cardiac or cerebrovascular events leading to hospitalization in the past three months Complex cardiovascular diseases: cyanotic congenital heart disease, moderate to severe pulmonary hypertension On regular medications that could affect the neurocognitive function and/or alertness
Where this trial is running
Kent Ridge, Please Select
- National University Hospital — Kent Ridge, Please Select, Singapore (Recruiting)
Study contacts
- Principal investigator: Chi-Hang Ronald Lee, MBBS, MD — National University Heart Centre, Singapore
- Study coordinator: Chi-Hang Lee, MBBS, MD
- Email: mdclchr@nus.edu.sg
- Phone: +6567722493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.