Status:
NOT_YET_RECRUITING
CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
National University of Singapore
Ng Teng Fong General Hospital
Conditions:
Obstructive Sleep Apnea (OSA)
Mild Cognitive Impairment
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Aim #1: The primary objective is to compare the effectiveness of MAD and CPAP in improving cognitive function in participants with OSA and cardiovascular risk. The key endpoints of the trial will incl...
Eligibility Criteria
Inclusion
- Age of at least 50 Chinese, Malay, Indian or Thai residing in Singapore or Thailand 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) At least one of the following cardiovascular risk factors: hypertension, diabetes, smoking, or obesity (BMI \>27.5 kg/m2)- cutoff for obesity among Asians 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06983769
Start Date
August 1 2025
End Date
December 31 2030
Last Update
June 27 2025
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