Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance

NCT02085720 | Completed Results

• 1 other identifier: Elderly OSA/Ng/2011
• Study Type: interventional
• Target: 819
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome; Restless Leg Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Prevalence of Restless Leg Syndrome (RLS)

  3 years

• CPAP Compliance Among Chinese Elderly

  1 year

• AHI Result

  1 year

• Sleep and Health Questionnaire Result

  1 year

Study Arms (1)

Chinese elderly OSAS

EXPERIMENTAL

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

Interventions

CPAP therapy DEVICE

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.

Chinese elderly OSAS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 60 years
• able to give consent

You may not qualify if:

• none

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Community centers for elderly

Hong Kong, Hong Kong SAR, Hong Kong

Location

Related Publications (13)

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  PMID: 15223874 BACKGROUND

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  PMID: 15781100 BACKGROUND

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  PMID: 21852330 BACKGROUND

• 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. doi: 10.1164/ajrccm.162.4.9907019.

  PMID: 11029353 BACKGROUND

• 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. doi: 10.1056/NEJM199304293281704.

  PMID: 8464434 BACKGROUND

• 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. doi: 10.1164/ajrccm.151.5.7735600.

  PMID: 7735600 BACKGROUND

• 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. doi: 10.1378/chest.119.1.62.

  PMID: 11157585 BACKGROUND

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

  PMID: 8222559 BACKGROUND

• 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. doi: 10.1046/j.1365-2869.1998.00103.x.

  PMID: 9682179 BACKGROUND

• 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.

  PMID: 20199644 BACKGROUND

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  PMID: 12608438 BACKGROUND

• 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. doi: 10.1378/chest.117.5.1410.

  PMID: 10807830 BACKGROUND

• 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. doi: 10.1164/ajrccm.158.2.9712036.

  PMID: 9700127 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Parasomnias; Mental Disorders

Limitations and Caveats

Subjects were chosen from the community centers and it is possible that those with more symptoms would be more eager to join the study; mre females than males; those who participated in the home sleep study were younger, with slightly higher ESS.

Results Point of Contact

• Title: Dr Susanna Ng SS
• Organization: Chinese University of Hong Kong

drsssng123@yahoo.com.hk

85226322211

Study Officials

• Susanna SS Ng, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: September 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: May 5, 2016
• Results First Posted: August 21, 2014

Record last verified: 2016-03

Locations

HK (1)