Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085720
• Other study ID #: Elderly OSA/Ng/2011
• Status: Completed
• Phase: N/A
• First received: March 7, 2014
• Last updated: August 4, 2014
• Start date: September 2007
• Est. completion date: August 2011

Study information

• Verified date: August 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• aged = 60 years

• able to give consent

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Restless Leg Syndrome
• Restless Legs Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Community centers for elderly	Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (13)

Barceló A, Piérola J, de la Peña M, Esquinas C, Sanchez-de la Torre M, Ayllón O, Alonso A, Agusti AG, Barbè F. Day-night variations in endothelial dysfunction markers and haemostatic factors in sleep apnoea. Eur Respir J. 2012 Apr;39(4):913-8. doi: 10.1183/09031936.00039911. Epub 2011 Aug 18. — View Citation

Bearpark H, Elliott L, Grunstein R, Cullen S, Schneider H, Althaus W, Sullivan C. Snoring and sleep apnea. A population study in Australian men. Am J Respir Crit Care Med. 1995 May;151(5):1459-65. — View Citation

Dingli K, Coleman EL, Vennelle M, Finch SP, Wraith PK, Mackay TW, Douglas NJ. Evaluation of a portable device for diagnosing the sleep apnoea/hypopnoea syndrome. Eur Respir J. 2003 Feb;21(2):253-9. — View Citation

Engleman HM, Douglas NJ. Sleep. 4: Sleepiness, cognitive function, and quality of life in obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Jul;59(7):618-22. Review. — View Citation

Feinsilver SH, Hertz G. Sleep in the elderly patient. Clin Chest Med. 1993 Sep;14(3):405-11. Review. — View Citation

Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503. — View Citation

Hui DS, Chan JK, Choy DK, Ko FW, Li TS, Leung RC, Lai CK. Effects of augmented continuous positive airway pressure education and support on compliance and outcome in a Chinese population. Chest. 2000 May;117(5):1410-6. — View Citation

Hume KI, Van F, Watson A. A field study of age and gender differences in habitual adult sleep. J Sleep Res. 1998 Jun;7(2):85-94. — View Citation

Ip MS, Lam B, Lauder IJ, Tsang KW, Chung KF, Mok YW, Lam WK. A community study of sleep-disordered breathing in middle-aged Chinese men in Hong Kong. Chest. 2001 Jan;119(1):62-9. — View Citation

Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. — View Citation

Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. — View Citation

Ng SS, Chan TO, To KW, Ngai J, Tung A, Ko FW, Hui DS. Validation of Embletta portable diagnostic system for identifying patients with suspected obstructive sleep apnoea syndrome (OSAS). Respirology. 2010 Feb;15(2):336-42. doi: 10.1111/j.1440-1843.2009.01697.x. — View Citation

Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 years	No
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.	3 years	No
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).	1 year	No
Secondary	AHI Result		1 year	No
Secondary	Sleep and Health Questionnaire Result		1 year	No