CPAP versus mandibular advancement mouthpiece for sleep apnea in people with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Choose Myself (Before) Losing Myself

  We’re testing an educational interactive booklet to help people with dementia or memory problems think about future medical decisions and start conversations with family or caregivers.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07846566

• F&P Mask usability in home PAP/NIV care for adults with chronic breathing conditions

  This study tests how well the F&P Licorice Mask works at home for adults who already use PAP or NIV therapy.

  Recruiting Fisher and Paykel Healthcare · St Louis, Missouri · NCT07826429

• Gut and Oral Microbiome and Cognitive Health in Aging

  This study tests whether differences in gut and mouth bacteria are linked to cognitive health in adults across ages and cognitive status.

  Recruiting University of South Florida · Tampa, Florida · NCT07799402

• Sleep apnea biomarkers and CPAP use after diagnosis

  This study tests whether biomarkers from a diagnostic sleep study can predict how well adults with newly diagnosed obstructive sleep apnea will stick to CPAP therapy after about 3 months.

  Recruiting Clinique du Millenaire · Montpellier · NCT07792746

• Using the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea

  This real-world study tests whether the PLATO questionnaire can be feasibly used in dental sleep clinics for patients receiving oral appliance therapy for obstructive sleep apnea.

  Recruiting Nevada Dental Sleep · Henderson, Nevada · NCT07789834

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.