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Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02085720
Enrollment
819
Registered
2014-03-13
Start date
2007-09-30
Completion date
2011-08-31
Last updated
2016-05-05

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

Conditions

Obstructive Sleep Apnea Syndrome, Restless Leg Syndrome

Brief summary

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.

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.

Interventions

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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* aged ≥ 60 years * able to give consent

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly3 yearsSubjects 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.

Secondary

MeasureTime frameDescription
Prevalence of Restless Leg Syndrome (RLS)3 yearsRLS 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.
CPAP Compliance Among Chinese Elderly1 yearElderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).
AHI Result1 year
Sleep and Health Questionnaire Result1 year

Countries

Hong Kong

Participant flow

Participants by arm

ArmCount
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. 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.
819
Total819

Baseline characteristics

CharacteristicChinese Elderly OSAS
Age, Continuous
Female
74.1 years
STANDARD_DEVIATION 7.6
Age, Continuous
Men
73.4 years
STANDARD_DEVIATION 6.9
Age, Continuous
Total
73.9 years
STANDARD_DEVIATION 7.5
Alcohol drinker
drinker
189 participants
Alcohol drinker
Non drinker
630 participants
Body mass index (BMI)
Female
24.2 kg/m^2
STANDARD_DEVIATION 3.7
Body mass index (BMI)
Men
24.3 kg/m^2
STANDARD_DEVIATION 3.3
Body mass index (BMI)
Total
24.2 kg/m^2
STANDARD_DEVIATION 3.6
Epworth Sleepiness Score
Female
6.5 units on a scale
STANDARD_DEVIATION 5.2
Epworth Sleepiness Score
Men
7.0 units on a scale
STANDARD_DEVIATION 5.2
Epworth Sleepiness Score
Total
6.6 units on a scale
STANDARD_DEVIATION 5.2
Neck circumference
Female
33.8 cm
STANDARD_DEVIATION 2.9
Neck circumference
Men
37.7 cm
STANDARD_DEVIATION 2.9
Neck circumference
Total
34.9 cm
STANDARD_DEVIATION 3.4
Region of Enrollment
Hong Kong
819 participants
Sex: Female, Male
Female
612 Participants
Sex: Female, Male
Male
207 Participants
Smoking status
Non smoker
696 participants
Smoking status
Smoker
123 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 819
serious
Total, serious adverse events
0 / 819

Outcome results

Primary

Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly

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.

Time frame: 3 years

ArmMeasureValue (NUMBER)
Chinese Elderly OSASPrevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly15 % of participants
p-value: <0.05ANOVA
Secondary

AHI Result

Time frame: 1 year

ArmMeasureGroupValue (NUMBER)
Chinese Elderly OSASAHI ResultAHI >/566.7 % of participants
Chinese Elderly OSASAHI ResultAHI >/1043.6 % of participants
Chinese Elderly OSASAHI ResultAHI >/1529.9 % of participants
Chinese Elderly OSASAHI ResultAHI >/2019.2 % of participants
Secondary

CPAP Compliance Among Chinese Elderly

Elderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Chinese Elderly OSASCPAP Compliance Among Chinese Elderly4.2 hoursStandard Deviation 2.2
Secondary

Prevalence of Restless Leg Syndrome (RLS)

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.

Time frame: 3 years

ArmMeasureValue (NUMBER)
Chinese Elderly OSASPrevalence of Restless Leg Syndrome (RLS)13.8 % of participants
Secondary

Sleep and Health Questionnaire Result

Time frame: 1 year

ArmMeasureGroupValue (NUMBER)
Chinese Elderly OSASSleep and Health Questionnaire ResultImpaired performance ability (mild)41.5 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultImpaired performance ability (moderate)8.5 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultImpaired performance ability8.7 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultSleepiness interfered with daily tasks (mild)10.2 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultSleepiness interfered with daily tasks (moderate)3.4 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultSleepiness interfered with daily tasks(severe)3.8 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultImpaired energy level (mild)39.2 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultImpaired energy level (moderate)8.0 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultImpaired energy level (severe)9.4 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultDaytime sleepiness (mild)41.1 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultDaytime sleepiness (moderate)8.5 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultDaytime sleepiness (severe)22.8 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultSnoring intensity (past month) (mild)33.0 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultSnoring intensity (past month) (moderate)8.2 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultSnoring intensity (past month) (severe)5.1 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultFrequent awakenings (mild)38.3 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultFrequent awakenings (moderate)8.6 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultFrequent awakenings (severe)19.3 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultDifficulty falling asleep (mild)48.4 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultDifficulty falling asleep (moderate)7.8 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultDifficulty falling asleep (severe)9.9 % of participants
Chinese Elderly OSASSleep and Health Questionnaire Resultobserved awakenings (mild)6.6 % of participants
Chinese Elderly OSASSleep and Health Questionnaire Resultobserved awakenings (moderate)0.7 % of participants
Chinese Elderly OSASSleep and Health Questionnaire Resultobserved choking (mild)2.8 % of participants
Chinese Elderly OSASSleep and Health Questionnaire Resultobserved choking (moderate)1.1 % of participants
Chinese Elderly OSASSleep and Health Questionnaire Resultobserved choking (severe)0.7 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultObserved apnea (mild)1.7 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultObserved apnea (moderate)0.4 % of participants
Chinese Elderly OSASSleep and Health Questionnaire ResultObserved apnea (severe)0.6 % of participants
Chinese Elderly OSASSleep and Health Questionnaire Resultobserved awakenings (severe)0.8 % of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026