NCT06983769 CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
| NCT ID | NCT06983769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University Hospital, Singapore |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2026-01-01 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Chi-Hang Ronald Lee, MBBS, MD
PRINCIPAL INVESTIGATOR
National University Heart Centre, Singapore
Frequently Asked Questions
Who can join the NCT06983769 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06983769 currently recruiting?
Yes, NCT06983769 is actively recruiting participants. Contact the research team at mdclchr@nus.edu.sg for enrollment information.
Where is the NCT06983769 trial being conducted?
This trial is being conducted at Kent Ridge, Singapore.
Who is sponsoring the NCT06983769 clinical trial?
NCT06983769 is sponsored by National University Hospital, Singapore. The principal investigator is Chi-Hang Ronald Lee, MBBS, MD at National University Heart Centre, Singapore. The trial plans to enroll 260 participants.