Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance

March 31, 2016 updated by: Susanna SS Ng, Chinese University of Hong Kong

Prevalence of Obstructive Sleep Apnea Syndrome and CPAP Adherence in the Elderly Chinese Population

Objective: Obstructive sleep apnoea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) causing sleep fragmentation, daytime sleepiness, cognitive function impairment, and poor health status in addition to increased risk of cardiovascular complications. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK) Chinese populations with a prevalence of at least 4%. However, the prevalence of OSAS in the elderly population in Asia including HK is unknown.

Study Design: A sleep questionnaire will be conducted for 1000 subjects aged at least 60 yrs in the elderly community centers focusing on symptoms of OSAS, subjective sleepiness, restless leg syndrome, and sleep-related habits and routines, in addition to past medical history and medications. Home sleep study (EMBLETTA) capable of recording sleep (a single EEG channel), respiratory events, snoring, respiratory efforts and oximetry will be performed on 300 subjects randomly. Those who have negative or technical inadequate EMBLETTA study with a high pre-test probability of moderate to severe OSA will be invited to undergo hospital-based polysomnography for confirmation of their sleep apnoea status. Subjects with AHI>15/hr regardless of symptoms or those with AHI 5-15/hr plus comorbid conditions or excessive daytime sleepiness will be offered continuous positive airway pressure (CPAP) titration followed by CPAP treatment, with serial assessment of subjective sleepiness, quality of life, and cognitive function.

Outcome measures: the prevalence rates of SDB (AHI>10, >15 and >30/hr), OSAS, and other sleep disturbances, such as restless leg syndrome (RLS). In addition, we will examine the factors which are predictive of the presence of SDB in this population, and assess the CPAP acceptance, compliance, and treatment outcome of those with OSAS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea syndrome (OSAS) is a common form of sleep-disordered breathing (SDB) characterized by repetitive episodes of cessation of breathing during sleep due to upper airway collapse. It causes sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor quality of life. In addition, OSAS is associated with non-fatal and fatal cardiovascular consequences including sudden death, in addition to an increased risk of road traffic accidents. OSAS is equally common among the middle-aged male Caucasian and Hong Kong (HK) Chinese populations with a prevalence of at least 4%. However, the prevalence of OSAS in the elderly in Southeast Asia is unknown. Sleep disturbances, such as daytime sleepiness, SDB and non-respiratory causes including insomnia, restless leg syndrome are common in the elderly. There are also more frequent and sometimes prolonged nocturnal awakenings, leading to a decline in sleep efficiency (total time asleep as percentage of time in bed). However, the disruption of sleep architecture can be exaggerated by the presence of OSAS. The associated hypersomnolence can exacerbate the normal tendency in older people to sleep during the day, affecting their functional independence.

While OSAS produces large negative impacts on health and quality of life, the recognition is not always straightforward because of the presence of co-morbidities and normal age-related changes in sleep quality and behavior. Once OSAS is suspected, it is not only relatively easy to diagnose, but usually responds well to treatment with CPAP.

Method A sleep questionnaire will be conducted for 1000 subjects aged at least 60 yrs in the elderly community centers focusing on symptoms of OSAS, subjective sleepiness, restless leg syndrome, and sleep-related habits and routines, in addition to past medical history and medications. Home sleep study with the EMBLETTA device capable of recording sleep (a single EEG channel), respiratory events, snoring, respiratory efforts and oximetry will be performed on 300 subjects randomly. Descriptions of the device and the validity of the methods used to collect and display data have been published previously among both local Chinese and other populations. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an AHI based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. The body position is detected by the built-in sensors. Respiratory events are scored when desaturations of at least 4% occurred in the absence of moving artifacts and irrespective of co-existing changes in snoring or heart rate. A hypopnea is defined as a decrease in airflow by 50% of baseline for at least 10 seconds. Data are included in the analysis if the total recorded evaluation time of 4 hrs or longer is obtained during the EMBLETTA study.

Those who have negative or technical inadequate EMBLETTA study with a high pre-test probability of moderate to severe OSA will be invited to undergo hospital-based polysomnography for confirmation of their sleep apnoea status.

As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) score ≥ 10 received patient education program. Subjects who agreed for CPAP therapy were offered basic CPAP education package consisting of a 10-min CPAP education programme by a respiratory nurse explaining the basic operation and care of the CPAP device and the mask, educational brochure on OSA and CPAP treatment in Chinese, and careful mask fitting, and a short trial of CPAP therapy with the an automatic CPAP machine (AUTOSET CPAP) device (RESMED, Sydney, Australia) for approximately 30 minutes for acclimatization in the afternoon. Attended CPAP titration will be performed with the AUTOSET auto-titrating device in our hospital. Throughout the night and the next morning the nurses on duty would deal with any discomfort related to the CPAP treatment. The CPAP pressure for each patient will be set at the minimal pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night as determined by the overnight AutoSet CPAP titration study. The patients subsequently will be followed up by physicians and nurses at the CPAP clinic in 1 month and 3 months later to deal with any problem with the CPAP device or mask fit. Subjects who agreed for home CPAP treatment will be prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea-specific quality of life index (SAQLI), and cognitive function tests will be performed at baseline and at 3 months after CPAP treatment.

Study Type

Interventional

Enrollment (Actual)

819

Phase

  • Not Applicable

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
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong
        • Community centers for elderly

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged ≥ 60 years
  • able to give consent

Exclusion Criteria:

  • none

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chinese elderly OSAS
Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.
Device: CPAP therapy
As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly
Time Frame: 3 years
Subjects who have completed the questionnaires and consented for sleep study are invited to undergo a portable at-home sleep study (EMBLETTA). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea hypopnea index (AHI) based on recording time. AHI is the average number of events per hour while 5-15 events per hour denotes mild OSA, 16-30 events moderate OSA, and >30 events severe OSA. Obstructive sleep apnea syndrome is defined as AHI 15 events or above or AHI being 5 or above pulus ESS 10 or more. This measure is reporting the percentage of participants with OSAS.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Restless Leg Syndrome (RLS)
Time Frame: 3 years
RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.
3 years
CPAP Compliance Among Chinese Elderly
Time Frame: 1 year
Elderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).
1 year
AHI Result
Time Frame: 1 year
1 year
Sleep and Health Questionnaire Result
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Susanna SS Ng, MBChB, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elderly OSA/Ng/2011

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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