CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 819 enrolled
Drug / intervention
CPAP therapydevice
Likely dose
Not stated in record
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Search/NCT02085720
NCT02085720N/ACompleted

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

Chinese University of Hong Kong·interventional·Posted Mar 13, 2014·Updated May 5, 2016

In Brief

A clinical study evaluating CPAP therapy for Obstructive Sleep Apnea Syndrome and Restless Leg Syndrome. Completed, enrolled 819 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2014
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.3 years ago

Interventions

CPAP therapydevice

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.