NCT04658290

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Aug 2020Aug 2026

Study Start

First participant enrolled

August 29, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

6 years

First QC Date

August 31, 2020

Last Update Submit

February 18, 2024

Conditions

Obstructive Sleep ApneaCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Number of subjects having apnea-hypopnea index of more than 5

    1 year

Secondary Outcomes (2)

  • incidence of cerebrovascular disease

    5 years

  • Montreal Cognitive Assessment

    5 years

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Have stability of at least 4 weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong

Hong Kong, Please Select, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

December 8, 2020

Study Start

August 29, 2020

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

HK(1)