Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02085720
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2014-03-07
Brief Title:
Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Prevalence of Obstructive Sleep Apnea Syndrome and CPAP Adherence in the Elderly Chinese Population
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AHI15hr regardless of symptoms or those with AHI 5-15hr 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 AHI10 15 and 30hr 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 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 AHI15hr regardless of symptoms or those with AHI 5-15hr 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 AHI10 15 and 30hr 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None