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

Phase 3

Recruiting

• Conditions: Mild Cognitive Impairment complecating Obstructive Sleep Apnoea; MCI/OSAS

• Registration Number: JPRN-jRCT1062220115
• Lead Sponsor: Fujii Masanori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified