Prevalence of Obstructive Sleep Apnea (OSA) and the Association With Cognitive Impairment

February 18, 2024 updated by: Susanna SS Ng, Chinese University of Hong Kong
The study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (OSA) and the association with cognitive impairment.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Please Select
      • Hong Kong, Please Select, Hong Kong
        • Recruiting
        • Chinese University of Hong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Consecutive subjects are recruited from the Brain Health Longitudinal Study which was launched in July 2019. Up to 5000 subjects aged 40-74 years without a confirmed brain disorder. Participants will be assigned to undergo a portable at-home sleep study which records the airflow, heart rate, body position and oxygen saturation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects having apnea-hypopnea index of more than 5
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of cerebrovascular disease
Time Frame: 5 years
5 years
Montreal Cognitive Assessment
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2020

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2026

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SleepBrain_2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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