ClinicalTrials.gg
CompletedNCT03280914Updated Feb 6, 2020

Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

An observational study in Sleep Apnea, Obstructive, Hypertension and Obesity, sponsored by Guangdong Provincial People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Guangdong Provincial People's Hospital · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
103
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 108 studies in Sleep Apnea, Obstructive with a site in China — 48 open to participants now, 50 under way, 10 of them phase 3. Sleep Apnea, Obstructive · China.

Enrollment
33rd of 47
103 · median 200
Started
2017
with 7 others
Observational
47 of 108
25 open now
Registered
21st of 108
by date

Among the 108 studies in Sleep Apnea, Obstructive with a site in China, this one is the 33rd largest by enrollment of the 47 observational ones that give a count, is one of 8 that started in 2017, is one of 47 observational ones, and was the 21st registered.

Sleep Apnea, Obstructive

2,242 studies on the registry are indexed under Sleep Apnea, Obstructive; 474 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Open to participants now

48 of the 108 studies in Sleep Apnea, Obstructive with a site in China are open now. Recruiting first, the newest first:

43 more — sign in →

All 48 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.

Read the detailed description

Patients with obstructive sleep apnea receiving CPAP or not would be observed in years. Primarily Impact of CPAP on health assessment andx control rate of hypertension would evaluated.

03

Conditions studied

  • Sleep Apnea, Obstructive
  • Hypertension
  • Obesity
  • Diabetes
  • Hyperdiploid
  • Fatigue Syndrome, Chronic
  • Insomnia Chronic
  • Quality of Life
  • Economic Problems
  • Compliance, Patient
  • Health Impairment

Keywords

  • obstructive sleep apnea
  • real world
  • community
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients would be recruited from Community of Huanghua Road.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. AHI >= 5 events/h

Exclusion criteria

Exclusion Criteria:

  1. Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe , heart failure in class III to IV, and others
  2. Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
  3. Patients receiving CPAP treatment
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • CPAP group

    Automatic Continuous Positive Airway Pressure treatment and usual care

    Device: Auto-CPAP

  • Usual care group

    Usual care without Continuous Positive Airway Pressure treatment

Interventions

  • DeviceAuto-CPAP

    Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea

06

What researchers measure

Primary outcomes

  1. Health assessment

    Health assessment would be performed by 36-Item Short-Form Health Survey.

    Time frame: From 1st Aug 2017 to 31st Dec 2020

  2. Sleep quality

    Sleep quality would be performed by Pittsburgh Sleep Quality Index.

    Time frame: From 1st Aug 2017 to 31st Dec 2020

  3. Psychological assessment

    Psychological assessment would be performed by Hospital Anxiety and Depression Scale.

    Time frame: From 1st Aug 2017 to 31st Dec 2020

  4. Control rate of hypertension

    Time frame: From 1st Aug 2017 to 31st Dec 2020

Secondary outcomes

  1. Incidence of chronic diseases

    Chronic diseases include hypertension, coronary heart disease, stroke and diabetes.

    Time frame: From 1st Aug 2017 to 31st Dec 2025

  2. Death from all-cause

    Time frame: From 1st Aug 2017 to 31st Dec 2025

  3. Medical cost

    Medical fee, annually time of outpatient visit and hospitalization

    Time frame: From 1st Aug 2017 to 31st Dec 2025

07

Study locations

1 site
  • Community of Huanghua Road
    Guangzhou, 510000, China
08

References and documents

Individual participant data

Plan to share: No — Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Dec 2019, 28 months.

Of 258 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's 28 months is close to that.

Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2017
First posted
Sep 13, 2017
StartActual
Aug 1, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Feb 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03280914
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Aug 1, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Feb 6, 2020

Study contacts

Qiong Ou, M.D.
principal investigator · Guangdong Provincial People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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