Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
ID06983769

Cognition Recovery in Sleep Apnea Patients With Cardiovascular Risk by Evaluating Nasal CPAP Versus Dental Oral Appliance

Led by National University Hospital, Singapore · Updated on 2026-01-21

260

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

N

National University Hospital, Singapore

Lead Sponsor

N

National University of Singapore

Collaborating Sponsor

AI-Summary

What this Trial Is About

Obstructive sleep apnea (OSA) is a common condition that causes breathing problems during sleep due to a blocked airway. It affects many adults worldwide and can lead to poor sleep, low oxygen levels, and increased health risks. People with OSA are more likely to develop cognitive problems, and the condition also results in a large economic burden. This trial aims to compare two treatments, continuous positive airway pressure (CPAP) and mandibular advancement devices (MAD), to see how they affect cognitive function and other health outcomes in adults with OSA and cardiovascular risks, focusing on Asian populations. Participants diagnosed with moderate-to-severe OSA and mild cognitive impairment will be randomly assigned to receive either CPAP or MAD treatment in equal groups. CPAP uses a machine to keep the airway open by providing constant air pressure during sleep, while MAD is a custom oral device that moves the lower jaw forward to prevent airway blockage. The study will include baseline assessments and follow-ups at six and twelve months, measuring cognitive function with the Montreal Cognitive Assessment (MoCA) and monitoring treatment adherence. During the trial, participants will undergo tests including brain MRI scans to explore brain structure and function, ambulatory blood pressure monitoring, sleep quality questionnaires, and assessments of sleep apnea severity. Researchers will track changes in cognitive function, device adherence, sleepiness levels, and biomarkers over time. The study will help understand how each treatment impacts cognitive recovery and other health measures over one year, with ongoing safety and outcome monitoring throughout the study period.

CONDITIONS

Brief Title

CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of at least 45 years
  • Chinese, Malay, or Indian ethnicity
  • Diagnosed with moderate-to-severe obstructive sleep apnea (AHI 215 events/hour)
  • Mild cognitive impairment (MoCA score <27 for >10 years education, <26 for 210 years education)
  • Agree to follow the study protocol
Not Eligible

You will not qualify if you...

  • Known obstructive sleep apnea already on regular treatment
  • Severe cognitive impairment (MoCA <10)
  • Severe hypoxemia on polysomnography (ODI >60 or minimum SpO2 <60%)
  • History of schizophrenia, bipolar disorder, severe depression, drug abuse, or alcohol abuse
  • Contraindications to MAD such as less than six teeth in each arch or inability to advance/open jaw
  • Pre-existing temporomandibular joint problems, severe bruxism, advanced periodontal disease
  • Life expectancy less than one year
  • Cardiac or cerebrovascular events leading to hospitalization in past three months
  • Complex cardiovascular diseases including cyanotic congenital heart disease or moderate to severe pulmonary hypertension
  • Use of medications that affect neurocognitive function or alertness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 12 months

Participants are fitted with and use either a Mandibular Advancement Device (MAD) or a Continuous Positive Airway Pressure (CPAP) machine to treat obstructive sleep apnea.

Baseline visit and follow-up visits at 6 months and 12 months

Follow-up

Duration - 12 months

Participants are monitored for cognitive function and device adherence after the intervention period.

Assessments at 6 months and 12 months post-baseline

Trial Site Locations

Total: 1 location

1

National University Hospital

Kent Ridge, Please Select, Singapore, 267383

Actively Recruiting

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Research Team

C

Chi-Hang Lee, MBBS, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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