Sleep Apnea, ObstructiveNCT03280914
Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community
An observational study of Sleep Apnea, Obstructive and Hypertension, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Hypertension, Obesity
- What is being tested?
- Auto-CPAP
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients would be recruited from Community of Huanghua Road.
Who may be able to join
- 1) AHI >= 5 events/h
Who cannot join
- Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV, and others
- Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
- Patients receiving CPAP treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community: a Real World Study
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.
- Conditions
- Sleep Apnea, Obstructive, Hypertension, Obesity, Diabetes, Hyperdiploid, Fatigue Syndrome, Chronic
- Being tested
- Auto-CPAP
- Keywords
- obstructive sleep apnea, real world, community
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Obesity, Diabetes Mellitus, Fatigue Syndrome, Chronic, Sleep Initiation and Maintenance Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-CPAPDevice
Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Automatic Continuous Positive Airway Pressure treatment and usual care Receives: Device: Auto-CPAP | |
| Usual care group | Usual care without Continuous Positive Airway Pressure treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health assessment
Health assessment would be performed by 36-Item Short-Form Health Survey.
Measured: From 1st Aug 2017 to 31st Dec 2020
Sleep quality
Sleep quality would be performed by Pittsburgh Sleep Quality Index.
Measured: From 1st Aug 2017 to 31st Dec 2020
Psychological assessment
Psychological assessment would be performed by Hospital Anxiety and Depression Scale.
Measured: From 1st Aug 2017 to 31st Dec 2020
Control rate of hypertension
Measured: From 1st Aug 2017 to 31st Dec 2020
Secondary outcomes (3)
Incidence of chronic diseases
Chronic diseases include hypertension, coronary heart disease, stroke and diabetes.
Measured: From 1st Aug 2017 to 31st Dec 2025
Death from all-cause
Measured: From 1st Aug 2017 to 31st Dec 2025
Medical cost
Medical fee, annually time of outpatient visit and hospitalization
Measured: From 1st Aug 2017 to 31st Dec 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiong Ou, M.D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280914
- Sponsor's protocol ID
- GDREC2016275H(R1)
- Status last verified
- Jun 2018
- First submitted
- 14 Aug 2017
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community: a Real World Study
- ClinicalTrials.gov ID
- NCT03280914
- Acronym / sponsor ID
- GDREC2016275H(R1)
- Conditions
- Sleep Apnea, Obstructive, Hypertension, Obesity, Diabetes, Hyperdiploid, Fatigue Syndrome, Chronic
- Keywords
- obstructive sleep apnea, real world, community
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP group | – | Device: Auto-CPAPAutomatic Continuous Positive Airway Pressure treatment and usual care |
| Usual care group | – | –Usual care without Continuous Positive Airway Pressure treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients would be recruited from Community of Huanghua Road.
Key inclusion criteria (1 listed)
- 1) AHI >= 5 events/h
Key exclusion criteria (3 listed)
- Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV, and others
- Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
- Patients receiving CPAP treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-CPAPAutomatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea | Device | CPAP group |
Primary outcome
Health assessment
Time frame: From 1st Aug 2017 to 31st Dec 2020
Health assessment would be performed by 36-Item Short-Form Health Survey.
Sleep quality
Time frame: From 1st Aug 2017 to 31st Dec 2020
Sleep quality would be performed by Pittsburgh Sleep Quality Index.
Psychological assessment
Time frame: From 1st Aug 2017 to 31st Dec 2020
Psychological assessment would be performed by Hospital Anxiety and Depression Scale.
Control rate of hypertension
Time frame: From 1st Aug 2017 to 31st Dec 2020
3 secondary outcomes
Incidence of chronic diseases
Time frame: From 1st Aug 2017 to 31st Dec 2025
Death from all-cause
Time frame: From 1st Aug 2017 to 31st Dec 2025
Medical cost
Time frame: From 1st Aug 2017 to 31st Dec 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No. Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiong Ou, M.D. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Hypertension, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health assessment (time frame: From 1st Aug 2017 to 31st Dec 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.