NCT06983769 · RECRUITING
CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
This trial compares two treatments for obstructive sleep apnea in people who already have mild cognitive impairment: a CPAP machine versus a mandibular advancement device, which is a custom mouthpiece that repositions the jaw during sleep. Researchers want to know which works better for preserving or improving cognitive function over one year. This is a Phase NA randomized trial — meaning it is comparing two existing approved approaches rather than testing a new experimental drug.
Eligibility 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-21