JPRN-jRCT1062220115
Recruiting
Phase 3
Randomised clinical trial to investigate the Efficacy of CPAP for Mild cognitive Impairment with Obstructive Sleep Apnoea - MORE
Fujii Masanori0 sites130 target enrollmentMarch 31, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fujii Masanori
- Enrollment
- 130
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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