Comparing a jaw device with CPAP for sleep apnea and memory problems

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for Chinese, Malay or Indian adults with moderate-to-severe obstructive sleep apnea and mild memory and thinking problems. It compares CPAP with a dental mouth device (MAD).

Age

45 years and older

Sex

All sexes

Disease stage

Moderate-to-severe obstructive sleep apnea (AHI ≥ 15 events/hour) found on a level 1 sleep study. Mild cognitive impairment.

Earlier treatment

People already known to have OSA and on regular treatment cannot join.

Biomarker or test result

MoCA score <27 (for those with >10 years of education) or <26 (for those with ≤10 years of education).

Main reasons for not taking part

• Severe cognitive impairment (MoCA <10) or very low oxygen during sleep (ODI >60 or min SpO2 <60%)
• Schizophrenia, bipolar disorder, severe depression, drug or alcohol abuse
• Teeth or jaw problems that rule out the mouth device, such as less than six teeth in each arch
• Heart or brain event needing hospital care in the past three months, or complex heart disease
• Life expectancy under one year, or regular medicines that affect thinking or alertness

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• CPAP armExisting treatment, for comparison

  CPAP stands for Continuous Positive Airway Pressure. It is the standard treatment for obstructive sleep apnea (OSA). A CPAP machine delivers a constant stream of air through a mask worn over the nose or nose and mouth during sleep. This air pressure keeps the airway open, preventing pauses in breathing caused by airway collapse. CPAP is highly effective, especially for moderate to severe OSA, but some patients may find it uncomfortable or difficult to tolerate.

  Treatment: CPAP

• MADTreatment being tested

  MAD stands for Mandibular Advancement Device. It is a custom-fitted oral appliance used primarily to treat obstructive sleep apnea (OSA) and snoring. The device works by gently advancing the lower jaw (mandible) forward, which helps keep the airway open during sleep by preventing the tongue and soft tissues from collapsing and blocking the airway. MADs are a non-invasive alternative to CPAP therapy and are especially suitable for patients with mild to moderate OSA or those who are intolerant to CPAP.