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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04658290
Other study ID # SleepBrain_2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 29, 2020
Est. completion date August 28, 2026

Study information

Verified date February 2024
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (OSA) and the association with cognitive impairment.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date August 28, 2026
Est. primary completion date August 28, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 74 Years
Eligibility Inclusion Criteria: - Have stability of at least 4 weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms). Exclusion Criteria: - Suspected dementia or a score of <24 on the mini-mental state examination - A diagnosis of neurological disorders (e.g. Parkinson's Disease, Epilepsy, Multiple Sclerosis) - Psychiatric disorders including current major depression; bipolar disorder; schizophrenia - Other known clinically significant sleep disorders (e.g. narcolepsy) - Been currently receiving CPAP or bi-level pressure for OSA

Study Design


Locations

Country Name City State
Hong Kong Chinese University of Hong Hong Kong Please Select

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects having apnea-hypopnea index of more than 5 1 year
Secondary incidence of cerebrovascular disease 5 years
Secondary Montreal Cognitive Assessment 5 years
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