Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06983769
Eligibility Criteria:
Inclusion Criteria:
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06983769
Study Brief:
Protocol Section:
NCT06983769