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

Randomised clinical trial to investigate the Efficacy of CPAP for Mild cognitive Impairment with Obstructive Sleep Apnoea - MORE

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1062220115
Enrollment
130
Registered
2023-03-31
Start date
2024-11-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment complecating Obstructive Sleep Apnoea MCI/OSAS

Interventions

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 princ
CPAP

Sponsors

Fujii Masanori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Change in the Japanese version of the Montreal Cognitive Assessment (MoCA-J) six months after the initial assessment.

Secondary

MeasureTime frame
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.

Contacts

Public ContactMasanori Fujii

Department of Geriatric Medicine, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University

feynman8@okayama-u.ac.jp+81-86-235-7227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026