Trial Outcomes & Findings for Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance (NCT NCT02085720)
NCT ID: NCT02085720
Last Updated: 2016-05-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
819 participants
Primary outcome timeframe
3 years
Results posted on
2016-05-05
Participant Flow
Participant milestones
| Measure |
Chinese Elderly OSAS
We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (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.
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|---|---|
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Overall Study
STARTED
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819
|
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Overall Study
COMPLETED
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819
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevalence of OSAS in Chinese Elderly and Its CPAP Compliance
Baseline characteristics by cohort
| Measure |
Chinese Elderly OSAS
n=819 Participants
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.
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|---|---|
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Age, Continuous
Total
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73.9 years
STANDARD_DEVIATION 7.5 • n=99 Participants
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Age, Continuous
Men
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73.4 years
STANDARD_DEVIATION 6.9 • n=99 Participants
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Age, Continuous
Female
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74.1 years
STANDARD_DEVIATION 7.6 • n=99 Participants
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Sex: Female, Male
Female
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612 Participants
n=99 Participants
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Sex: Female, Male
Male
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207 Participants
n=99 Participants
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Region of Enrollment
Hong Kong
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819 participants
n=99 Participants
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Body mass index (BMI)
Total
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24.2 kg/m^2
STANDARD_DEVIATION 3.6 • n=99 Participants
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Body mass index (BMI)
Men
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24.3 kg/m^2
STANDARD_DEVIATION 3.3 • n=99 Participants
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Body mass index (BMI)
Female
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24.2 kg/m^2
STANDARD_DEVIATION 3.7 • n=99 Participants
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Neck circumference
Total
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34.9 cm
STANDARD_DEVIATION 3.4 • n=99 Participants
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Neck circumference
Men
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37.7 cm
STANDARD_DEVIATION 2.9 • n=99 Participants
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Neck circumference
Female
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33.8 cm
STANDARD_DEVIATION 2.9 • n=99 Participants
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Smoking status
Non smoker
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696 participants
n=99 Participants
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Smoking status
Smoker
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123 participants
n=99 Participants
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Alcohol drinker
Non drinker
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630 participants
n=99 Participants
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Alcohol drinker
drinker
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189 participants
n=99 Participants
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Epworth Sleepiness Score
Total
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6.6 units on a scale
STANDARD_DEVIATION 5.2 • n=99 Participants
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Epworth Sleepiness Score
Men
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7.0 units on a scale
STANDARD_DEVIATION 5.2 • n=99 Participants
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Epworth Sleepiness Score
Female
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6.5 units on a scale
STANDARD_DEVIATION 5.2 • n=99 Participants
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PRIMARY outcome
Timeframe: 3 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.
Outcome measures
| Measure |
Chinese Elderly OSAS
n=819 Participants
We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (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.
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Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly
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15 % of participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Chinese Elderly OSAS
n=819 Participants
We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (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.
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Prevalence of Restless Leg Syndrome (RLS)
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13.8 % of participants
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SECONDARY outcome
Timeframe: 1 yearElderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).
Outcome measures
| Measure |
Chinese Elderly OSAS
n=30 Participants
We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (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.
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CPAP Compliance Among Chinese Elderly
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4.2 hours
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Chinese Elderly OSAS
n=234 Participants
We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (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.
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|---|---|
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AHI Result
AHI >/5
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66.7 % of participants
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AHI Result
AHI >/10
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43.6 % of participants
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AHI Result
AHI >/15
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29.9 % of participants
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AHI Result
AHI >/20
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19.2 % of participants
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SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Chinese Elderly OSAS
n=819 Participants
We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.
CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (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.
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|---|---|
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Sleep and Health Questionnaire Result
Observed apnea (severe)
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0.6 % of participants
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Sleep and Health Questionnaire Result
Impaired energy level (severe)
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9.4 % of participants
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Sleep and Health Questionnaire Result
Daytime sleepiness (mild)
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41.1 % of participants
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Sleep and Health Questionnaire Result
Daytime sleepiness (moderate)
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8.5 % of participants
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Sleep and Health Questionnaire Result
Daytime sleepiness (severe)
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22.8 % of participants
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Sleep and Health Questionnaire Result
Snoring intensity (past month) (mild)
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33.0 % of participants
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Sleep and Health Questionnaire Result
Snoring intensity (past month) (moderate)
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8.2 % of participants
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Sleep and Health Questionnaire Result
Snoring intensity (past month) (severe)
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5.1 % of participants
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Sleep and Health Questionnaire Result
Frequent awakenings (mild)
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38.3 % of participants
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Sleep and Health Questionnaire Result
Frequent awakenings (moderate)
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8.6 % of participants
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Sleep and Health Questionnaire Result
Frequent awakenings (severe)
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19.3 % of participants
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Sleep and Health Questionnaire Result
Difficulty falling asleep (mild)
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48.4 % of participants
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Sleep and Health Questionnaire Result
Difficulty falling asleep (moderate)
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7.8 % of participants
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Sleep and Health Questionnaire Result
Difficulty falling asleep (severe)
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9.9 % of participants
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Sleep and Health Questionnaire Result
observed awakenings (mild)
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6.6 % of participants
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Sleep and Health Questionnaire Result
observed awakenings (moderate)
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0.7 % of participants
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Sleep and Health Questionnaire Result
observed awakenings (severe)
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0.8 % of participants
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Sleep and Health Questionnaire Result
observed choking (mild)
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2.8 % of participants
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Sleep and Health Questionnaire Result
observed choking (moderate)
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1.1 % of participants
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Sleep and Health Questionnaire Result
observed choking (severe)
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0.7 % of participants
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Sleep and Health Questionnaire Result
Observed apnea (mild)
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1.7 % of participants
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Sleep and Health Questionnaire Result
Observed apnea (moderate)
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0.4 % of participants
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Sleep and Health Questionnaire Result
Impaired performance ability (mild)
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41.5 % of participants
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Sleep and Health Questionnaire Result
Impaired performance ability (moderate)
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8.5 % of participants
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Sleep and Health Questionnaire Result
Impaired performance ability
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8.7 % of participants
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Sleep and Health Questionnaire Result
Sleepiness interfered with daily tasks (mild)
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10.2 % of participants
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Sleep and Health Questionnaire Result
Sleepiness interfered with daily tasks (moderate)
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3.4 % of participants
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Sleep and Health Questionnaire Result
Sleepiness interfered with daily tasks(severe)
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3.8 % of participants
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Sleep and Health Questionnaire Result
Impaired energy level (mild)
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39.2 % of participants
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Sleep and Health Questionnaire Result
Impaired energy level (moderate)
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8.0 % of participants
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Adverse Events
Chinese Elderly OSAS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place