MCI patients with OSAS Randomised clinical trial to investigate the Efficacy of CPAP (MORE)

JRCT ID: jRCT1062220115

Registered date:31/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild Cognitive Impairment complecating Obstructive Sleep Apnoea
• Date of first enrollment: 31/03/2023
• Target sample size: 130
• Study type: Interventional

Intervention(s)

Continuous Positive Airway Pressure (CPAP)
1)CPAP intervention group
Induction of CPAP, followed by an outpatient visit every month for mask fitting and adjustment of the appropriate pressure.In principle, outpatients are required every month for mask fitting and adjustment of the appropriate pressure. The goal is to maintain good adherence (wear rate of at least 70% for at least 4 hours).
2)Regular care group
Patients are followed up at OSAS outpatient clinics and memory loss outpatient clinics. If necessary, lifestyle guidance will be given (those with lifestyle-related diseases such as hypertension will be instructed to eat well and exercise regularly, smokers will be instructed to stop smoking and drink moderately).
If there is a request for CPAP induction 6 (within 3months before and after is acceptable) months after enrollment, CPAP induction and the same medical care as in the CPAP group will be provided.

Outcome(s)

• Primary Outcome: Change in the Japanese version of the Montreal Cognitive Assessment (MoCA-J) six months after the initial assessment.
• Secondary Outcome: Amount of change in each cognitive function, sleep and quality of life test after 6 and 12 months, whether or not dementia has developed, sleep EEG, cerebral blood flow, changes in gut microbiota, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Aged 50 years and over
2) AHI over 20 on polysomnography or AHI over 40 on brief monitoring with a confirmed diagnosis of OSAS
3) Patients with a clinical diagnosis of MCI based on DSM-5 (Diagnostic & Statistical Manual of Mental Disorders,5th edition) or NIA-AA (National Institute on Aging-Alzheimer Association Joint Working Group) diagnostic criteria.
4) Cases in which the attending physician is able to judge that CPAP treatment is possible, and cases in which the patient lives with or has a family member who can support the patient as a study partner throughout the course of treatment (at least 3 times a week face to face or telephone contact is possible).
5) After receiving a full explanation of the study, select patients who have been fully informed about their participation in the study, and who have given their written consent, either by themselves or by a proxy, with full understanding.

Exclude criteria

1) A respiratory event index of 60 or more on an out of center sleep testing or an apnoea-hypopnoea index of 60 or more on a Polysomnography
2) Psychiatric disorders such as depression and schizophrenia
3) Delirium
4) Parkinson's disease
5) Medical conditions affecting cognitive function (hypothyroidism, parathyroid disorders, vitamin B12 and folic acid deficiency, neurosyphilis, neuro-Beichet's disease and other collagen diseases, severe diabetes, chronic liver disorders, chronic respiratory diseases, hypoglycaemia, etc.)
6) Epilepsy
7) Neurosurgical diseases (e.g. brain tumours, chronic subdural haematomas, normal hydrocephalus) and massive stroke cases
8) Cases of new prescriptions or volume changes of dementia drugs in the last 3 months
9) Cases with a history of excessive alcohol consumption or alcohol dependence
10) Patients with severe visual or hearing impairment that interferes with daily life.

Related Information

• Primary Sponsor: Fujii Masanori